510(k) K191391 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
HEDRON Lumbar Spacers
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | May 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191391
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.