510(k) K232504 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Calibrate CCX Interbody System
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 13, 2023 |
| Received | Aug 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2025 | Alphatec Spine, Inc. Calibrate CCX Interbody System for spinal fusion procedures:
Implants:
(1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile;
(2) Calibrate CCX-O, 7 x 10 x 25mm 10 degree Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.