510(k) K191243 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
HEDRON Cervical Spacers
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Sep 17, 2019 |
| Received | May 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191243
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.