elıxdata
Dispositivos MédicosCancelado

INSTRUMENTAIS CIRÚRGICOS INERTIA

82274000004

Registro cancelado em 13/02/2023 segundo a ANVISA.

Informações Gerais

Nome do produto

INSTRUMENTAIS CIRÚRGICOS INERTIA

Número de registro

82274000004

Classe de risco

I

Processo

25351492808202276

Empresa Detentora

Fabricante

NEXXT SPINE LLC

País de fabricação

ESTADOS UNIDOS DA AMÉRICA

Registro

Situação

Cancelado

Vencimento

Vence em 383 dias16/11/2027
Histórico de Situação

Nenhuma mudança de situação registrada.

Apresentações / Modelos(75)

  • I10-01-26

    Axial Ratchet Handle 1/4” Square Connect*

  • I10-01-27

    Palm Ratchet Handle 1/4” Square Connect*

  • I10-02-18

    In-Situ Driver, T15, X15TN

  • I10-02-20

    Head Positioner

  • I10-02-25

    Final Driver T25, 1/4 Sq. Adapter

  • I10-04-25

    I10-01-11 Screw Inserter, Auto-Locking*

  • I10-05-03

    Duckbill Curved Probe (pear) (lumbar)*

  • I10-05-04

    Lenke Straight Probe (pear) (thoracic)

  • I10-05-05

    Lenke Curved Probe (pear) (thoracic)

  • I10-05-06

    Ball Tip Sounder - Curved

  • I10-05-06

    Ball Tip Sounder - Curved -Screw & I10-33-07 Polyaxial Screw Inserter* -Cap Inserters I10-33-19 Polyaxial Screw Inserter -I10-33-08 Screw Inserter Sleeve

  • I10-05-07

    Lenke Straight Probe (pear) (lumbar)*

  • I10-05-08

    Lenke Curved Probe (pear) (lumbar)*

  • I10-05-09

    Lenke Straight Probe (gear) (lumbar)*

  • I10-05-10

    Lenke Curved Probe (gear) (lumbar)*

  • I10-05-11

    Duckbill Straight Probe (gear) (lumbar)*

  • I10-05-12

    Duckbill Curved Probe (gear) (lumbar)*

  • I10-06-45

    Tap, double lead, Ø4.5mm

  • I10-06-45

    Tap, double lead, Ø4.5mm - I10-06-55 Tap, double lead, Ø5.5mm - I10-06-65 Tap, double lead, Ø6.5mm -I10-06-70 Tap, double lead, Ø7.0mm* - I10-06-70 Tap, double lead, Ø7.5mm*

  • I10-06-55

    Tap, double lead, Ø5.5mm

  • I10-06-65

    Tap, double lead, Ø6.5mm

  • I10-06-70

    Tap, double lead, Ø7.0mm*

  • I10-06-70

    Tap, double lead, Ø7.5mm*

  • I10-06-85

    Tap, double lead, Ø8.5mm*

  • I10-06-85

    Tap, double lead, Ø8.5mm* Probes I10-06-95 -I10-06- 105 I10-05-02Tap, double lead, Ø9.5mm* Tap, double lead, Ø10.5mm* Duckbill Straight Probe (pear) (lumbar)*- I10-05- Duckbill Curved Probe (pear) (lumbar)* I10-05-04 Lenke Straight Probe (pear)

  • I10-10-04

    Distractor - parallel

  • I10-10-04

    Distractor - parallel -I10-11-04 Compressor - parallel

  • I10-11-04

    Compressor - parallel

  • I10-13-01

    I10-15-07 In-Situ Rod Bende -Awl -Alignment Tube - Revision I10-15-08 Anti-Torque Tube/Handle -Instruments 9.5 & 10.5 I10-33-05 - I10-33-06 I10-15-11 Polyaxial Screw Inserter Revision - Screw Inserter Sleeve Revision 95105 Counter Torque -Revisi

  • I10-15-06

    I10-08-06 Alignment Tube

  • I10-30-06

    French Rod Bender

  • I10-30-06

    French Rod Bender - 8.5 & 9.0 - I10-30-05L&R - I10-13- 01 I10- 15-07

  • I10-31-02

    I10-32- 02 I10- 32-06 Forcep Reducer Linked Reducer* Tower Reducer -I10-32-07

  • I10-32-02

    I10-32-06 Forcep Reducer

  • I10-32-07

    Tower Reducer, Adapter

  • I10-33-08

    Screw Inserter Sleeve

  • 10-25-C45* 10-25-C60I10-01-48 I10-28-01 I10-28-02 I10-28-04 I10-28-05 I10-28-03* HandlesI10-01-25 Ratchet T Handle - I10-01-26 Axial Ratchet Handle 1/4” Square Connect*

  • 8.5 & 9.0 I10-30-05L

  • 95105 Counter Torque

  • Alignment Tube - Anti-Torque Tube/Handle - Thin Rod Holder - Pusher I10-09-02 Thin Rod Pusher* -Reducers -Other

  • Anti-Torque Tube/Handle Thin Rod Holder

  • Cap Inserters I10-33-19 Polyaxial Screw Inserter

  • Crosslynxx, Bender, Left Crosslynxx Driver, SQR Crosslynxx Measuring Calipers Crosslynxx Measuring Template

  • Double Lead I10-01-07 I10-01-08 I10-06-35S Ratchet Straight Handle* Ratchet Palm Handle*

  • Duckbill Straight Probe (pear) (lumbar)*

  • Final Tighten -I10-33-24 -I10-04- 25 I10- 01-11

  • Final Tighten I10-33-24

  • Handles I10-01-25 Ratchet T Handle

  • I10-15-05

  • In-Situ Rod Bender -Awl - Alignment Tube -Revision I10-15-08 Anti-Torque Tube/Handle

  • IN/LBS10-26-EE5555Handle-Axial, SQR, Torque Limiting, 40 in-lb Crosslynxx, Bender, Right

  • Instruments I10-01-58 Torque Limiting Handle 110

  • Instruments I10-33-05 Polyaxial Screw Inserter - Revision INERTIA®

  • Linked Reducer* Tower Reducer

  • MIS Distractor/Compressor Body -1 Level Distractor Arm -1 Level Compressor Arm -2 Level Compressor Arm - Locking Collar - MIS Final Set Screw Driver -Torque Limiter 90 In. Lbs.

  • Ø5.5/5.5 Connector, Double Open Wedding Ø5.5/5.5 Connector, Single Open Wedding10-26-DM5555 - 10-26-WD5555 - 10-26-DW -10-26-SW10-25-C25 -10-25-C30 -10-25-C35 -10-25-C40*

  • Ø5.5/5.5 Connector, Inline Ø5.5/5.5 Connector, Domino Ø5.5/5.5 Connector, Wedding

  • Other I10-31-02

  • Pedicle Screw System16 -9.5 & 10.5 -I10-33- 06 I10- 15-11

  • Probes I10-06-95 I10-06-105 I10-05-02 Tap, double lead, Ø9.5mm* Tap, double lead, Ø10.5mm*

  • Pusher I10-09-02 Thin Rod Pusher*

  • Reducers

  • Revision I10-33-26 95105 Polyaxial Screw Inserter

  • Rod Holder

  • Rod Holder, - I10-15-05 -I10-15- 06 I10- 08-06

  • Screw & I10-33-07 Polyaxial Screw Inserter*

  • Screw Inserter Sleeve Revision

  • Screw Inserter, Auto-Locking*

  • Set Screw Inserter T25

  • Sounders I10-05-01 Ball Tip Sounder - Straight

  • Tap, double lead, shallow, Ø3.5mm*

  • Tap, double lead, shallow, Ø3.5mm* Taps I10-06-45S Tap, double lead, shallow Ø4.5mm*

  • Taps I10-06-45S Tap, double lead, shallow Ø4.5mm*

  • Torque T Handle 1/4 Sq. 90inlb

  • Tower Reducer, Adapter - I10-02-18 In-Situ Driver, T15, X15TN -I10-02-20 Head Positioner

Documentos Técnicos(1)

489235922116/11/2022

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

Faça seu cadastro grátis e consulte sem limite