INSTRUMENTAIS CIRÚRGICOS INERTIA
Registro cancelado em 13/02/2023 segundo a ANVISA.
Nome do produto
INSTRUMENTAIS CIRÚRGICOS INERTIA
Número de registro
82274000004
Nome técnico
Classe de risco
I
Processo
25351492808202276
Fabricante
País de fabricação
ESTADOS UNIDOS DA AMÉRICA
Apresentações / Modelos(75)
I10-01-26Axial Ratchet Handle 1/4” Square Connect*
I10-01-27Palm Ratchet Handle 1/4” Square Connect*
I10-02-18In-Situ Driver, T15, X15TN
I10-02-20Head Positioner
I10-02-25Final Driver T25, 1/4 Sq. Adapter
I10-04-25I10-01-11 Screw Inserter, Auto-Locking*
I10-05-03Duckbill Curved Probe (pear) (lumbar)*
I10-05-04Lenke Straight Probe (pear) (thoracic)
I10-05-05Lenke Curved Probe (pear) (thoracic)
I10-05-06Ball Tip Sounder - Curved
I10-05-06Ball Tip Sounder - Curved -Screw & I10-33-07 Polyaxial Screw Inserter* -Cap Inserters I10-33-19 Polyaxial Screw Inserter -I10-33-08 Screw Inserter Sleeve
I10-05-07Lenke Straight Probe (pear) (lumbar)*
I10-05-08Lenke Curved Probe (pear) (lumbar)*
I10-05-09Lenke Straight Probe (gear) (lumbar)*
I10-05-10Lenke Curved Probe (gear) (lumbar)*
I10-05-11Duckbill Straight Probe (gear) (lumbar)*
I10-05-12Duckbill Curved Probe (gear) (lumbar)*
I10-06-45Tap, double lead, Ø4.5mm
I10-06-45Tap, 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*
I10-06-55Tap, double lead, Ø5.5mm
I10-06-65Tap, double lead, Ø6.5mm
I10-06-70Tap, double lead, Ø7.0mm*
I10-06-70Tap, double lead, Ø7.5mm*
I10-06-85Tap, double lead, Ø8.5mm*
I10-06-85Tap, 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)
I10-10-04Distractor - parallel
I10-10-04Distractor - parallel -I10-11-04 Compressor - parallel
I10-11-04Compressor - parallel
I10-13-01I10-15-07 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
I10-15-06I10-08-06 Alignment Tube
I10-30-06French Rod Bender
I10-30-06French Rod Bender - 8.5 & 9.0 - I10-30-05L&R - I10-13- 01 I10- 15-07
I10-31-02I10-32- 02 I10- 32-06 Forcep Reducer Linked Reducer* Tower Reducer -I10-32-07
I10-32-02I10-32-06 Forcep Reducer
I10-32-07Tower Reducer, Adapter
I10-33-08Screw 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)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 4892359221Primária | 16/11/2022 | MATERIAL – Notificação de Dispositivo Médico Classe I | Publicado deferimento |
MATERIAL – Notificação de Dispositivo Médico Classe I
Publicado deferimento
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