510(k) K143578 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Apr 13, 2016 |
| Received | Dec 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143578
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.