510(k) K163543 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Biomet Fusion System
| Applicant | Zimmer Biomet Spine, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Feb 28, 2017 |
| Received | Dec 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163543
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.