Vector™ Pedicle Screw System
FDA 510(k) clearance K241276 · decided 2024-05-20
Clearance details
- K-number
- K241276
- Device name
- Vector™ Pedicle Screw System
- Applicant
- Innovasis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-06
- Decision date
- 2024-05-20
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System recall (Z-2859-2026) | Innovasis, Inc | 2026-08-03 |