510(k) K142487 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Chesapeake Stabilization System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, May 7, 2015 |
| Received | Sep 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2021 | K2M, Inc Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.