Cortera Spinal Fixation System
FDA 510(k) clearance K221403 · decided 2022-08-19
Clearance details
- K-number
- K221403
- Device name
- Cortera Spinal Fixation System
- Applicant
- Surgalign Spine Technologies
- Decision
- Substantially Equivalent
- Date received
- 2022-05-16
- Decision date
- 2022-08-19
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 recall (Z-0125-2025) | XTANT Medical Holdings, Inc | 2024-10-17 |
| Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 m recall (Z-0846-2024) | XTANT Medical Holdings, Inc | 2024-01-29 |