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Dispositivos MédicosAtivo

Instrumentos para procedimento de revisão em articulação de joelho

80686360284
Informações Gerais

Nome do produto

Instrumentos para procedimento de revisão em articulação de joelho

Número de registro

80686360284

Nome técnico

Kit Instrumental

Classe de risco

I

Processo

25351693383202059

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(209)

  • 104-02-00 - Nut

  • 104-901-09 - Medullary Reamer-9

  • 104-901-10 - Medullary Reamer-10

  • 104-901-11 - Medullary Reamer-11

  • 104-901-12 - Medullary Reamer-12

  • 104-901-13 - Medullary Reamer-13

  • 104-901-14 - Medullary Reamer-14

  • 104-901-15 - Medullary Reamer-15

  • 104-901-16 - Medullary Reamer-16

  • 104-901-90 - Femoral Medullary Locator

  • 104-902-02 - Femoral Cutting Device 2#

  • 104-902-03 - Femoral Cutting Device 3#

  • 104-902-04 - Femoral Cutting Device 4#

  • 104-902-05 - Femoral Cutting Device 5#

  • 104-902-06 - Femoral Cutting Device 6#

  • 104-902-07 - Femoral Cutting Device 7#

  • 104-902-10 - Guide-10

  • 104-902-12 - Guide-12

  • 104-902-15 - Guide-15

  • 104-902-18 - Guide-18

  • 104-902-90 - Precondyle localizer

  • 104-902-91 - Line Device

  • 104-902-93 - Posterior Cutting Guide

  • 104-903-00 - Offset Guide

  • 104-904-16 - φ16.7 Reamer

  • 104-904-18 - φ18 Reamer

  • 104-905-02 - Femoral Intercondylar Cutting Plate 2#

  • 104-905-03 - Femoral Intercondylar Cutting Plate 3#

  • 104-905-04 - Femoral Intercondylar Cutting Plate 4#

  • 104-905-05 - Femoral Intercondylar Cutting Plate 5#

  • 104-905-06 - Femoral Intercondylar Cutting Plate 6#

  • 104-905-07 - Femoral Intercondylar Cutting Plate 7#

  • 104-905-90 - Medullary Locator

  • 104-906-01 - Straight Stem Trial（φ9-80）

  • 104-906-02 - Straight Stem Trial（φ9-120）

  • 104-906-03 - Straight Stem Trial（φ9-150）

  • 104-906-04 - Straight Stem Trial（φ10-80）

  • 104-906-05 - Straight Stem Trial （φ10-120）

  • 104-906-06 - Straight Stem Trial（φ10-150）

  • 104-906-07 - Straight Stem Trial（φ11-80）

  • 104-906-08 - Straight Stem Trial （φ11-120）

  • 104-906-09 - Straight Stem Trial（φ11-150）

  • 104-906-10 - Straight Stem Trial（φ12-80）

  • 104-906-11 - Straight Stem Trial （φ12-120）

  • 104-906-12 - Straight Stem Trial （φ12-150）

  • 104-906-13 - Straight Stem Trial （φ13-80）

  • 104-906-14 - Straight Stem Trial（φ13-120）

  • 104-906-15 - Straight Stem Trial （φ13-150）

  • 104-906-16 - Straight Stem Trial（φ14-80）

  • 104-906-17 - Straight Stem Trial （φ14-120）

  • 104-906-18 - Straight Stem Trial （φ14-150）

  • 104-906-19 - Straight Stem Trial（φ15-80）

  • 104-906-20 - Straight Stem Trial（φ15-120）

  • 104-906-21 - Straight Stem Trial （φ15-150）

  • 104-906-22 - Straight Stem Trial（φ16-80）

  • 104-906-23 - Straight Stem Trial （φ16-120）

  • 104-906-24 - Straight Stem Trial （φ16-150）

  • 104-907-01 - Stem Trial with offset （9-120）

  • 104-907-02 - Stem Trial with offset （9-150）

  • 104-907-03 - Stem Trial with offset （10-120）

  • 104-907-04 - Stem Trial with offset （10-150）

  • 104-907-05 - Stem Trial with offset （11-120）

  • 104-907-06 - Stem Trial with offset （11-150）

  • 104-907-07 - Stem Trial with offset （12-120）

  • 104-907-08 - Stem Trial with offset （12-150）

  • 104-907-09 - Stem Trial with offset （13-120）

  • 104-907-10 - Stem Trial with offset （13-150）

  • 104-907-11 - Stem Trial with offset （14-120）

  • 104-907-12 - Stem Trial with offset （14-150）

  • 104-907-13 - Stem Trial with offset （15-120）

  • 104-907-14 - Stem Trial with offset （15-150）

  • 104-907-15 - Stem Trial with offset （16-120）

  • 104-907-16 - Stem Trial with offset （16-150）

  • 104-908-00 - Fixation Screw

  • 104-908-20 - XN Femoral Condyle Trial 2#-L

  • 104-908-21 - XN Femoral Condyle Trial 2#-R

  • 104-908-30 - XN Femoral Condyle Trial 3#-L

  • 104-908-31 - XN Femoral Condyle Trial 3#-R

  • 104-908-40 - XN Femoral Condyle Trial 4#-L

  • 104-908-41 - XN Femoral Condyle Trial 4#-R

  • 104-908-50 - XN Femoral Condyle Trial 5#-L

  • 104-908-51 - XN Femoral Condyle Trial 5#-R

  • 104-908-60 - XN Femoral Condyle Trial 6#-L

  • 104-908-61 - XN Femoral Condyle Trial 6#-R

  • 104-908-70 - XN Femoral Condyle Trial 7#-L

  • 104-908-71 - XN Femoral Condyle Trial 7#-R

  • 104-909-00 - Nut

  • 104-910-00 - Wrench

  • 104-911-90 - Tibia Medullary Guide

  • 104-911-91 - Reamer Sleeves

  • 104-912-00 - Stem Trial connector

  • 104-913-90 - Tibial Cutting Block A

  • 104-913-91 - Tibial Cutting Block B

  • 104-913-92 - Tibial Cutting Block C

  • 104-913-93 - Compression position A

  • 104-913-94 - Compression position B

  • 104-913-95 - Compression position C

  • 104-914-91 - Alignment Measurement Device

  • 104-915-00 - Offset Guide

  • 104-916-00 - Guide A

  • 104-917-00 - Guide B

  • 104-918-02 - Tibial Tray Trial 2#

  • 104-918-03 - Tibial Tray Trial 3#

  • 104-918-04 - Tibial Tray Trial 4#

  • 104-918-05 - Tibial Tray Trial 5#

  • 104-918-06 - Tibial Tray Trial 6#

  • 104-918-07 - Tibial Tray Trial 7#

  • 104-919-00 - Screw

  • 104-919-21 - Femoral Block Trials 2#-5

  • 104-919-22 - Femoral Block Trials 2#-10

  • 104-919-31 - Femoral Block Trials 3#-5

  • 104-919-32 - Femoral Block Trials 3#-10

  • 104-919-41 - Femoral Block Trials 4#-5

  • 104-919-42 - Femoral Block Trials 4#-10

  • 104-919-51 - Femoral Block Trials 5#-5

  • 104-919-52 - Femoral Block Trials 5#-10

  • 104-919-61 - Femoral Block Trials 6#-5

  • 104-919-62 - Femoral Block Trials 6#-10

  • 104-919-71 - Femoral Block Trials 7#-5

  • 104-919-72 - Femoral Block Trials 7#-10

  • 104-920-21 - Posterior Condyle Trials 2#-5

  • 104-920-22 - Posterior Condyle Trials 2#-10

  • 104-920-31 - Posterior Condyle Trials 3#-5

  • 104-920-32 - Posterior Condyle Trials 3#-10

  • 104-920-41 - Posterior Condyle Trials 4#-5

  • 104-920-42 - Posterior Condyle Trials 4#-10

  • 104-920-51 - Posterior Condyle Trials 5#-5

  • 104-920-52 - Posterior Condyle Trials 5#-10

  • 104-920-61 - Posterior Condyle Trials 6#-5

  • 104-920-62 - Posterior Condyle Trials 6#-10

  • 104-920-71 - Posterior Condyle Trials 7#-5

  • 104-920-72 - Posterior Condyle Trials 7#-10

  • 104-921-20 - Trial Insert 2/3/4#-9

  • 104-921-21 - Trial Insert 2/3/4#-11

  • 104-921-23 - Trial Insert 2/3/4#-13

  • 104-921-25 - Trial Insert 2/3/4#-15

  • 104-921-27 - Trial Insert 2/3/4#-17

  • 104-921-29 - Trial Insert 2/3/4#-19

  • 104-921-50 - Trial Insert 5/6#-9

  • 104-921-51 - Trial Insert 5/6#-11

  • 104-921-53 - Trial Insert 5/6#-13

  • 104-921-55 - Trial Insert 5/6#-15

  • 104-921-57 - Trial Insert 5/6#-17

  • 104-921-59 - Trial Insert 5/6#-19

  • 104-921-70 - Trial Insert 7#-9

  • 104-921-71 - Trial Insert 7#-11

  • 104-921-73 - Trial Insert 7#-13

  • 104-921-75 - Trial Insert 7#-15

  • 104-921-77 - Trial Insert 7#-17

  • 104-921-79 - Trial Insert 7#-19

  • 104-922-21 - Tibial Half Wedge Trial 2#-5-L

  • 104-922-22 - Tibial Half Wedge Trial 2#-5-R

  • 104-922-23 - Tibial Half Wedge Trial 2#-10-L

  • 104-922-24 - Tibial Half Wedge Trial 2#-10-R

  • 104-922-31 - Tibial Half Wedge Trial 3#-5-L

  • 104-922-32 - Tibial Half Wedge Trial 3#-5-R

  • 104-922-33 - Tibial Half Wedge Trial 3#-10-L

  • 104-922-34 - Tibial Half Wedge Trial 3#-10-R

  • 104-922-41 - Tibial Half Wedge Trial 4#-5-L

  • 104-922-42 - Tibial Half Wedge Trial 4#-5-R

  • 104-922-43 - Tibial Half Wedge Trial 4#-10-L

  • 104-922-44 - Tibial Half Wedge Trial 4#-10-R

  • 104-922-51 - Tibial Half Wedge Trial 5#-5-L

  • 104-922-52 - Tibial Half Wedge Trial 5#-5-R

  • 104-922-53 - Tibial Half Wedge Trial 5#-10-L

  • 104-922-54 - Tibial Half Wedge Trial 5#-10-R

  • 104-922-61 - Tibial Half Wedge Trial 6#-5-L

  • 104-922-62 - Tibial Half Wedge Trial 6#-5-R

  • 104-922-63 - Tibial Half Wedge Trial 6#-10-L

  • 104-922-64 - Tibial Half Wedge Trial 6#-10-R

  • 104-922-71 - Tibial Half Wedge Trial 7#-5-L

  • 104-922-72 - Tibial Half Wedge Trial 7#-5-R

  • 104-922-73 - Tibial Half Wedge Trial 7#-10-L

  • 104-922-74 - Tibial Half Wedge Trial 7#-10-R

  • 104-923-21 - Trial for Tibial Total Wedge with Angel 2#-L

  • 104-923-22 - Trial for Tibial Total Wedge with Angel 2#-R

  • 104-923-31 - Trial for Tibial Total Wedge with Angel 3#-L

  • 104-923-32 - Trial for Tibial Total Wedge with Angel 3#-R

  • 104-923-41 - Trial for Tibial Total Wedge with Angel 4#-L

  • 104-923-42 - Trial for Tibial Total Wedge with Angel 4#-R

  • 104-923-51 - Trial for Tibial Total Wedge with Angel 5#-L

  • 104-923-52 - Trial for Tibial Total Wedge with Angel 5#-R

  • 104-923-61 - Trial for Tibial Total Wedge with Angel 6#-L

  • 104-923-62 - Trial for Tibial Total Wedge with Angel 6#-R

  • 104-923-71 - Trial for Tibial Total Wedge with Angel 7#-L

  • 104-923-72 - Trial for Tibial Total Wedge with Angel 7#-R

  • 104-924-21 - Trial for Tibial Half Wedge with Angel 2#-L

  • 104-924-22 - Trial for Tibial Half Wedge with Angel 2#-R

  • 104-924-31 - Trial for Tibial Half Wedge with Angel 3#-L

  • 104-924-32 - Trial for Tibial Half Wedge with Angel 3#-R

  • 104-924-41 - Trial for Tibial Half Wedge with Angel 4#-L

  • 104-924-42 - Trial for Tibial Half Wedge with Angel 4#-R

  • 104-924-51 - Trial for Tibial Half Wedge with Angel 5#-L

  • 104-924-52 - Trial for Tibial Half Wedge with Angel 5#-R

  • 104-924-61 - Trial for Tibial Half Wedge with Angel 6#-L

  • 104-924-62 - Trial for Tibial Half Wedge with Angel 6#-R

  • 104-924-71 - Trial for Tibial Half Wedge with Angel 7#-L

  • 104-924-72 - Trial for Tibial Half Wedge with Angel 7#-R

  • 104-925-91 - Nail B-56

  • 104-925-92 - Nail B-76

  • 104-926-90 - Tray Holder

  • 104-927-90 - 3.5 Hexagon wrench A

  • 104-927-91 - 3.5 Hexagon wrench B

  • 104-927-92 - 2.5 Hexagon wrench A

  • 104-928-90 - 2.5 Hexagon wrench

  • 104-929-90 - Stem Impactor

  • 104-931-00 - φ8 Drill

  • 104-932-90 - Adaptor

  • 104-933-90 - Trial Insert Extractor.

Instruções de Uso e Arquivos(1)

IFU_Inst Knee Revision.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1950222417/04/2023, 14:01Exp. 0382792238

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

Documentos Técnicos(1)

235783820623/07/2020

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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