VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
FDA 510(k) clearance K193423 · decided 2020-05-22
Clearance details
- K-number
- K193423
- Device name
- VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
- Applicant
- Icotec AG
- Decision
- Substantially Equivalent
- Date received
- 2019-12-09
- Decision date
- 2020-05-22
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- 9450 Altstaetten (Sg), CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 recall (Z-0728-2023) | Icotec Ag | 2022-12-19 |