510(k) K221403 ยท NKB Thoracolumbosacral Pedicle Screw System
Cortera Spinal Fixation System
| Applicant | Surgalign Spine Technologies, Deerfield IL, US |
| Decision | Substantially Equivalent, Aug 19, 2022 |
| Received | May 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2024 | XTANT Medical Holdings, Inc Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 Open, Classified |
NKB | None listed |
| Jan 29, 2024 | XTANT Medical Holdings, Inc Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.