510(k) K232097 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
IdentiTi ALIF Interbody Systems
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 25, 2023 |
| Received | Jul 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2024 | Alphatec Spine, Inc. IdentiTi ALIF Standalone Interbody System:
Part Number/Description
132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm
132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm
132-10-85-350 / I Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.