510(k) K083389 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
COALITION SPACER
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Mar 26, 2009 |
| Received | Nov 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083389
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.