510(k) K162446 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Sep 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162446
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.