elıxdata
Dispositivos MédicosAtivo

Instrumentos para procedimento primário em articulação de joelho

80686360285
Informações Gerais

Nome do produto

Instrumentos para procedimento primário em articulação de joelho

Número de registro

80686360285

Nome técnico

Kit Instrumental

Classe de risco

I

Processo

25351693386202092

Empresa Detentora

Razão social

MANDALA BRASIL IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTO MÉDICO HOSPITALAR LTDA

CNPJ

09.117.476/0001-81

Fabricante

BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO.,LTD.

País de fabricação

CHINA, REPÚBLICA POPULAR

Registro

Situação

Ativo

Vencimento

Registro vigente

Registro de prazo indeterminado

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(371)

  • 102-901-90 - Tibia Cutting Block-L

  • 102-901-91 - Tibia Cutting Block-R

  • 102-901-92 -Deep Probe

  • 102-902-90 - Tibia External Positioning Rod

  • 102-903-90 - Positioning rod

  • 102-904-91 - Femoral fixed pin-A

  • 102-904-92 - Femoral fixed pin-B

  • 102-905-90 - Intramedullary Positioning Device

  • 102-906-00 - Planar Measurement Device (small)

  • 102-906-01 - Planar Measurement Device (big)

  • 102-907-90 - Distal Femur Cutting Blocck

  • 102-908-91 - Cutting Measurement Device

  • 102-908-92 - Femoral Sizing Guide

  • 102-908-93 - 0-3 lock L

  • 102-908-94 - 5-7 lock L

  • 102-908-95 - 0-3 lock R

  • 102-908-96 - 5-7 lock R

  • 102-909-02 - 4 in 1 Cutting Block 2#

  • 102-909-03 - 4 in 1 Cutting Block 3#

  • 102-909-04 - 4 in 1 Cutting Block 4#

  • 102-909-05 - 4 in 1 Cutting Block 5#

  • 102-909-06 - 4 in 1 Cutting Block 6#

  • 102-909-07 - 4 in 1 Cutting Block 7#

  • 102-909-08 - 4 in 1 Cutting Block 8#

  • 102-909-10 - 4 in 1 Cutting Block 10#

  • 102-909-10 - Screws

  • 102-909-11 - Connector

  • 102-910-90 - Femoral condyle Impactor

  • 102-911-90 - Condyle holder

  • 102-912-90 - Hammer

  • 102-913-02 - 2# Metal trial

  • 102-913-03 - 3# Metal trial

  • 102-913-04 - 4# Metal trial

  • 102-913-05 - 5# Metal trial

  • 102-913-06 - 6# Metal trial

  • 102-913-07 - 7# Metal trial

  • 102-913-08 - 8# Metal trial

  • 102-913-10 - 10# Metal trial

  • 102-914-90 - Alignment Measuring Handle

  • 102-914-91 - Alignment measuring Rod A

  • 102-914-92 - Alignment measuring Rod B

  • 102-915-24 - 2#/3#/4#Tibia drill guide 102-915-68 - 5#/6#/7#/8#/10#Tibia drill guide

  • 102-916-24 - 2#/3#/4#Tibial Medullary reamer

  • 102-916-68 - 5#/6#/7#/8#/10# Tibial Medullary reamer

  • 102-917-09 - Trial Spacer 9#

  • 102-917-11 - Trial Spacer 11#

  • 102-917-13 - Trial Spacer 13#

  • 102-917-15 - Trial Spacer 15#

  • 102-917-17 - Trial Spacer 17#

  • 102-917-19 - Trial Spacer 19#

  • 102-918-25 - Nail A-25

  • 102-918-40 - Nail A-40

  • 102-918-56 - Nail B-56

  • 102-918-60 - Nail A-60

  • 102-918-76 - Nail B-76

  • 102-919-90 - Nails Connector

  • 102-920-11 - Tibial Trial Inserts-PS-10#-9

  • 102-920-12 - Tibial Trial Inserts-PS-10#-11

  • 102-920-13 - Tibial Trial Inserts-PS-10#-13

  • 102-920-14 - Tibial Trial Inserts-PS-10#-15

  • 102-920-15 - Tibial Trial Inserts-PS-10#-17

  • 102-920-16 - Tibial Trial Inserts-PS-10#-19

  • 102-920-21 - Tibial Trial Inserts-PS-2#-9

  • 102-920-22 - Tibial Trial Inserts-PS-2#-11

  • 102-920-23 - Tibial Trial Inserts-PS-2#-13

  • 102-920-24 - Tibial Trial Inserts-PS-2#-15

  • 102-920-25 - Tibial Trial Inserts-PS-2#-17

  • 102-920-26 - Tibial Trial Inserts-PS-2#-19

  • 102-920-31 - Tibial Trial Inserts-PS-3/4#-9

  • 102-920-32 - Tibial Trial Inserts-PS-3/4#-11

  • 102-920-33 - Tibial Trial Inserts-PS-3/4#-13

  • 102-920-34 - Tibial Trial Inserts-PS-3/4#-15

  • 102-920-35 - Tibial Trial Inserts-PS-3/4#-17

  • 102-920-36 - Tibial Trial Inserts-PS-3/4#-19

  • 102-920-51 - Tibial Trial Inserts-PS-5/6#-9

  • 102-920-52 - Tibial Trial Inserts-PS-5/6#-11

  • 102-920-53 - Tibial Trial Inserts-PS-5/6#-13

  • 102-920-54 - Tibial Trial Inserts-PS-5/6#-15

  • 102-920-55 - Tibial Trial Inserts-PS-5/6#-17

  • 102-920-56 - Tibial Trial Inserts-PS-5/6#-19

  • 102-920-71 - Tibial Trial Inserts-PS-7/8#-9

  • 102-920-72 - Tibial Trial Inserts-PS-7/8#-11

  • 102-920-73 - Tibial Trial Inserts-PS-7/8#-13

  • 102-920-74 - Tibial Trial Inserts-PS-7/8#-15

  • 102-920-75 - Tibial Trial Inserts-PS-7/8#-17

  • 102-920-76 - Tibial Trial Inserts-PS-7/8#-19

  • 102-921-11 - Tibial Trial Inserts-CR-10#-9

  • 102-921-12 - Tibial Trial Inserts-CR-10#-11

  • 102-921-13 - Tibial Trial Inserts-CR-10#-13

  • 102-921-14 - Tibial Trial Inserts-CR-10#-15

  • 102-921-15 - Tibial Trial Inserts-CR-10#-17

  • 102-921-16 - Tibial Trial Inserts-CR-10#-19

  • 102-921-21 - Tibial Trial Inserts-CR-2#-9

  • 102-921-22 - Tibial Trial Inserts-CR-2#-11

  • 102-921-23 - Tibial Trial Inserts-CR-2#-13

  • 102-921-24 - Tibial Trial Inserts-CR-2#-15

  • 102-921-25 - Tibial Trial Inserts-CR-2#-17

  • 102-921-26 - Tibial Trial Inserts-CR-2#-19

  • 102-921-31 - Tibial Trial Inserts-CR-3/4#-9

  • 102-921-32 - Tibial Trial Inserts-CR-3/4#-11

  • 102-921-33 - Tibial Trial Inserts-CR-3/4#-13

  • 102-921-34 - Tibial Trial Inserts-CR-3/4#-15

  • 102-921-35 - Tibial Trial Inserts-CR-3/4#-17

  • 102-921-36 - Tibial Trial Inserts-CR-3/4#-19

  • 102-921-51 - Tibial Trial Inserts-CR-5/6#-9

  • 102-921-52 - Tibial Trial Inserts-CR-5/6#-11

  • 102-921-53 - Tibial Trial Inserts-CR-5/6#-13

  • 102-921-54 - Tibial Trial Inserts-CR-5/6#-15

  • 102-921-55 - Tibial Trial Inserts-CR-5/6#-17

  • 102-921-56 - Tibial Trial Inserts-CR-5/6#-19

  • 102-921-71 - Tibial Trial Inserts-CR-7/8#-9

  • 102-921-72 - Tibial Trial Inserts-CR-7/8#-11

  • 102-921-73 - Tibial Trial Inserts-CR-7/8#-13

  • 102-921-74 - Tibial Trial Inserts-CR-7/8#-15

  • 102-921-75 - Tibial Trial Inserts-CR-7/8#-17

  • 102-921-76 - Tibial Trial Inserts-CR-7/8#-19

  • 102-922-90 - Tibia Tray Impactor

  • 102-923-90 - Alignment Measuring Device

  • 102-924-90 - Femoral Medullary Locator

  • 102-925-00 - Handle

  • 102-925-02 - 2# Intercondylar osteotomy plate

  • 102-925-03 - 3# Intercondylar osteotomy plate

  • 102-925-04 - 4# Intercondylar osteotomy plate

  • 102-925-05 - 5# Intercondylar osteotomy plate

  • 102-925-06 - 6# Intercondylar osteotomy plate

  • 102-925-07 - 7# Intercondylar osteotomy plate

  • 102-925-08 - 8# Intercondylar osteotomy plate

  • 102-925-10 - 10# Intercondylar osteotomy plate

  • 102-926-10 - 10#Curved Femoral Chisel

  • 102-926-21 - 2#/3#/4#Curved Femoral Chisel

  • 102-926-68 - 5#/6#/7#/8#Curved Femoral Chisel

  • 102-927-02 - 2#Box Osteotomy Device

  • 102-927-04 - 3#/4#Box Osteotomy Device

  • 102-927-06 - 5#/6#Box Osteotomy Device

  • 102-927-08 - 7#/8#Box Osteotomy Device

  • 102-927-10 - 10#Box Osteotomy Device

  • 102-928-00 - Prong Handle A

  • 102-928-01 - Prong Handle B

  • 102-929-02 - 2#Box Osteotomy Impactor

  • 102-929-04 - 3#/4#Box Osteotomy Impactor

  • 102-929-06 - 5#/6#Box Osteotomy Impactor

  • 102-929-08 - 7#/8#Box Osteotomy Impactor

  • 102-929-10 - 10#Box Osteotomy Impactor

  • 102-930-90 - Nail Pliers

  • 102-931-90 - Insert Impactor

  • 102-932-02 - Femoral Condyle Trials 2#-L

  • 102-932-03 - Femoral Condyle Trials 3#-L

  • 102-932-04 - Femoral Condyle Trials 4#-L

  • 102-932-05 - Femoral Condyle Trials 5#-L

  • 102-932-06 - Femoral Condyle Trials 6#-L

  • 102-932-07 - Femoral Condyle Trials 7#-L

  • 102-932-08 - Femoral Condyle Trials 8#-L

  • 102-932-10 - Femoral Condyle Trials 10#-L

  • 102-933-10 - 10#Femoral Measurement Device

  • 102-933-24 - 2#/4#Femoral Measurement Device

  • 102-933-68 - 6#/8#Femoral Measurement Device

  • 102-934-91 - Patella Masuring Device φ26-φ29

  • 102-934-92 - Patella Masuring Device φ32-φ35

  • 102-935-90 - Patella Caliper

  • 102-936-89 - Patella Compression Clamp-B

  • 102-936-90 - Patella Compression Clamp-A

  • 102-936-91 - Patella Cutting Device

  • 102-937-24 - 2#/3#/4#Tibia drill guide sleeve

  • 102-937-68 - 5#/6#/7#/8#/10#Tibia drill guide sleeve

  • 102-937-90 - Ankle Fixation Device

  • 102-938-03 - Drill φ3

  • 102-938-08 - Drill φ8

  • 102-939-05 - Reamer φ5

  • 102-939-06 - Reamer φ6

  • 102-939-14 - Reamer φ14

  • 102-939-15 - Reamer φ15

  • 102-940-11 - Patella Trial 26#-8

  • 102-940-12 - Patella Trial 26#-10

  • 102-940-13 - Patella Trial 26#-12

  • 102-940-21 - Patella Trial 29#-8

  • 102-940-22 - Patella Trial 29#-10

  • 102-940-23 - Patella Trial 29#-12

  • 102-940-31 - Patella Trial 32#-8

  • 102-940-32 - Patella Trial 32#-10

  • 102-940-33 - Patella Trial 32#-12

  • 102-940-41 - Patella Trial 35#-8

  • 102-940-42 - Patella Trial 35#-10

  • 102-940-43 - Patella Trial 35#-12

  • 102-941-00 - 3.5 Hexagon wrench

  • 102-942-02 - Femoral Condyle Trials 2#-R

  • 102-942-03 - Femoral Condyle Trials 3#-R

  • 102-942-04 - Femoral Condyle Trials 4#-R

  • 102-942-05 - Femoral Condyle Trials 5#-R

  • 102-942-06 - Femoral Condyle Trials 6#-R

  • 102-942-07 - Femoral Condyle Trials 7#-R

  • 102-942-08 - Femoral Condyle Trials 8#-R

  • 102-942-10 - Femoral Condyle Trials 10#-R

  • 102-943-45 - Block-5mm

  • 102-943-50 - Block-50mm

  • 102-944-00 - Insert Extractor

  • 102-945-00 - Arc Osteotome

  • 102-946-00 - Rasp

  • 102-947-00 - Handle

  • 103-901-00 - Handle

  • 103-902-90 - Tibia External Positioning Rod

  • 103-903-90 - Tibia External Postioning Rod

  • 103-904-91 - Tibia Cutting Block-L

  • 103-904-92 - Tibia Cutting Block-M

  • 103-904-93 - Tibia Cutting Block-R

  • 103-905-90 - Cutting Measurement Device（big）

  • 103-905-91 - Cutting Measurement Device（small）

  • 103-906-90 - Prong Handle-A

  • 103-906-91 - Prong Handle-B

  • 103-907-90 - Deep Probe

  • 103-908-90 - Alignment measuring Rod A

  • 103-908-91 - Alignment measuring Rod B

  • 103-909-12 - 1#/2# Femoral Measurement Device

  • 103-909-34 - 3#/4# Femoral Measurement Device

  • 103-909-56 - 5#/6# Femoral Measurement Device

  • 103-909-78 - 7#/8# Femoral Measurement Device

  • 103-910-90 - Femoral Canal Drill Guide

  • 103-911-90 - Ankle Fixation Device

  • 103-912-90 - Femoral Medullary Guide

  • 103-912-91 - Femoral Broach-165

  • 103-912-92 - Femoral Broach-235

  • 103-912-93 - Femoral Broach-300

  • 103-913-90 - Distal Femur Cutting Block

  • 103-914-00 - Alignment Measuring Rod

  • 103-915-90 - Impactor

  • 103-916-90 - Alignment Measuring Handle

  • 103-917-90 - Nail Pliers

  • 103-918-10 - Trial Spacer-10

  • 103-918-12 - Trial Spacer-12

  • 103-918-14 - Trial Spacer-14

  • 103-918-16 - Trial Spacer-16

  • 103-918-18 - Trial Spacer-18

  • 103-919-90 - Measurer

  • 103-919-91 - Measuring body

  • 103-919-92 - 0, 3 Measuring bone cutting guide (L)

  • 103-919-93 - 0, 3 Measuring bone cutting guide (R)

  • 103-919-94 - 5,7 Measuring bone cutting guide (L)

  • 103-919-95 - 5,7 Measuring bone cutting guide (R)

  • 103-919-96 - 0, 3 Measuring bone cutting guide (L)

  • 103-919-97 - 5,7 Measuring bone cutting guide (R)

  • 103-919-98 - 5,7 Measuring bone cutting guide (L)

  • 103-919-99 - 0, 3 Measuring bone cutting guide (R)

  • 103-920-01 - 1# 4 in 1 Cutting Block

  • 103-920-02 - 2# 4 in 1 Cutting Block

  • 103-920-03 - 3# 4 in 1 Cutting Block

  • 103-920-04 - 4# 4 in 1 Cutting Block

  • 103-920-05 - 5# 4 in 1 Cutting Block

  • 103-920-06 - 6# 4 in 1 Cutting Block

  • 103-920-07 - 7# 4 in 1 Cutting Block

  • 103-920-08 - 8# 4 in 1 Cutting Block

  • 103-921-90 - Plate file

  • 103-923-90 - Rasp

  • 103-924-10 - Trial Inserts 1#（PS）-10

  • 103-924-12 - Trial Inserts 1#（PS）-12

  • 103-924-14 - Trial Inserts 1#（PS）-14

  • 103-924-16 - Trial Inserts 1#（PS）-16

  • 103-924-18 - Trial Inserts 1#（PS）-18

  • 103-924-20 - Trial Inserts 2#-4#（PS）-10

  • 103-924-22 - Trial Inserts 2#-4#（PS）-12

  • 103-924-24 - Trial Inserts 2#-4#（PS）-14

  • 103-924-26 - Trial Inserts 2#-4#（PS）-16

  • 103-924-28 - Trial Inserts 2#-4#（PS）-18

  • 103-924-50 - Trial Inserts 5#-6#（PS）-10

  • 103-924-52 - Trial Inserts 5#-6#（PS）-12

  • 103-924-54 - Trial Inserts 5#-6#（PS）-14

  • 103-924-56 - Trial Inserts 5#-6#（PS）-16

  • 103-924-58 - Trial Inserts 5#-6#（PS）-18

  • 103-924-70 - Trial Inserts 7#-8#（PS）-10

  • 103-924-72 - Trial Inserts 7#-8#（PS）-12

  • 103-924-74 - Trial Inserts 7#-8#（PS）-14

  • 103-924-76 - Trial Inserts 7#-8#（PS）-16

  • 103-924-78 - Trial Inserts 7#-8#（PS）-18

  • 103-925-10 - Trial Inserts 1#（CR）-10

  • 103-925-12 - Trial Inserts 1#（CR）-12

  • 103-925-14 - Trial Inserts 1#（CR）-14

  • 103-925-16 - Trial Inserts 1#（CR）-16

  • 103-925-18 - Trial Inserts 1#（CR）-18

  • 103-925-20 - Trial Inserts 2#-4#（CR）-10

  • 103-925-22 - Trial Inserts 2#-4#（CR）-12

  • 103-925-24 - Trial Inserts 2#-4#（CR）-14

  • 103-925-26 - Trial Inserts 2#-4#（CR）-16

  • 103-925-28 - Trial Inserts 2#-4#（CR）-18

  • 103-925-50 - Trial Inserts 5#-6#（CR）-10

  • 103-925-52 - Trial Inserts 5#-6#（CR）-12

  • 103-925-54 - Trial Inserts 5#-6#（CR）-14

  • 103-925-56 - Trial Inserts 5#-6#（CR）-16

  • 103-925-58 - Trial Inserts 5#-6#（CR）-18

  • 103-925-70 - Trial Inserts 7#-8#（CR）-10

  • 103-925-72 - Trial Inserts 7#-8#（CR）-12

  • 103-925-74 - Trial Inserts 7#-8#（CR）-14

  • 103-925-76 - Trial Inserts 7#-8#（CR）-16

  • 103-925-78 - Trial Inserts 7#-8#（CR）-18

  • 103-926-9 - Long Nail

  • 103-926-9 - Ring Groove Nail

  • 103-926-93 - Thread Nail

  • 103-927-71 - 7#-R Femoral Condyle Trials

  • 103-927-80 - 8#-L Femoral Condyle Trials

  • 103-927-81 - 8#-R Femoral Condyle Trials

  • 103-927-90 - Femoral Condyle Holder

  • 103-928-10 - 1#-L Femoral Condyle Trials

  • 103-928-11 - 1#-R Femoral Condyle Trials

  • 103-928-20 - 2#-L Femoral Condyle Trials

  • 103-928-21 - 2#-R Femoral Condyle Trials

  • 103-928-30 - 3#-L Femoral Condyle Trials

  • 103-928-31 - 3#-R Femoral Condyle Trials

  • 103-928-40 - 4#-L Femoral Condyle Trials

  • 103-928-41 - 4#-R Femoral Condyle Trials

  • 103-928-50 - 5#-L Femoral Condyle Trials

  • 103-928-51 - 5#-R Femoral Condyle Trials

  • 103-928-60 - 6#-L Femoral Condyle Trials

  • 103-928-61 - 6#-R Femoral Condyle Trials

  • 103-928-70 - 7#-L Femoral Condyle Trials

  • 103-929-01 - 1# Femoral Condyle Trials intercondylar

  • 103-929-02 - 2# Femoral Condyle Trials intercondylar

  • 103-929-03 - 3# Femoral Condyle Trials intercondylar

  • 103-929-04 - 4# Femoral Condyle Trials intercondylar

  • 103-929-05 - 5# Femoral Condyle Trials intercondylar

  • 103-929-06 - 6# Femoral Condyle Trials intercondylar

  • 103-929-07 - 7# Femoral Condyle Trials intercondylar

  • 103-929-08 - 8# Femoral Condyle Trials intercondylar

  • 103-930-01 - 1# Tibia Metal Trial

  • 103-930-02 - 2# Tibia Metal Trial

  • 103-930-03 - 3# Tibia Metal Trial

  • 103-930-04 - 4# Tibia Metal Trial

  • 103-930-05 - 5# Tibia Metal Trial

  • 103-930-06 - 6# Tibia Metal Trial

  • 103-930-07 - 7# Tibia Metal Trial

  • 103-930-08 - 8# Tibia Metal Trial

  • 103-931-91 - φ6 Drill

  • 103-931-92 - φ3 Drill

  • 103-932-90 - Box Osteotomy Impactor

  • 103-932-90 - Tibia Trial Handle

  • 103-933-00 - φ20 Reamer

  • 103-933-01 - 1# Intercondylar osteotome

  • 103-933-02 - 2/3/4# Intercondylar osteotome

  • 103-933-05 - 5/6# Intercondylar osteotome

  • 103-933-07 - 7/8# Intercondylar osteotome

  • 103-933-93 - φ8 Drill

  • 103-933-94 - φ5 Drill

  • 103-934-91 - Nails A-25

  • 103-934-92 - Nails A-40

  • 103-934-93 - Nails A-60

  • 103-935-01 - 1# Tibia Reamer

  • 103-935-26 - 2#-6# Tibia Reamer

  • 103-935-78 - 7#-8# Tibia Reamer

  • 103-936-90 - Tibia Reamer

  • 103-937-90 - Tibia Tray Impactor

  • 103-937-90 - Femoral Impactor

  • 103-938-91 - Nails B-56

  • 103-938-92 - Nails B-76

  • 103-939-90 - Insert Impactor

  • 103-940-90 - Insert Extractor

  • 103-941-90 - Patella Cutting Device

  • 103-941-91 - Patella Compression Clamp

  • 103-941-92 - Patella Compression Clamp

  • 103-942-90 - Patella Caliper

  • 103-943-90 - Patella Masuring Device-26/28

  • 103-943-91 - Patella Masuring Device-30/32

  • 103-944-11 - Patella Trial-26-8

  • 103-944-12 - Patella Trial-26-10

  • 103-944-13 - Patella Trial-26-12

  • 103-944-21 - Patella Trial-28-8

  • 103-944-22 - Patella Trial-28-10

  • 103-944-23 - Patella Trial-28-12

  • 103-944-31 - Patella Trial-30-8

  • 103-944-32 - Patella Trial-30-10

  • 103-944-33 - Patella Trial-30-12

  • 103-944-41 - Patella Trial-32-8

  • 103-944-42 - Patella Trial-32-10

  • 103-944-43 - Patella Trial-32-12.

  • 103-947-90 - Quick connector

  • 103-948-00 - Nails Connector

Instruções de Uso e Arquivos(1)

IFU_Inst Knee Primary.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1950212717/04/2023, 13:55Exp. 0382697235

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(1)

235784520923/07/2020

MATERIAL – Notificação de Dispositivo Médico Classe I

Publicado deferimento

Petição primária

Produtos relacionados

Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
Ver na fonte oficial da ANVISA

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