510(k) K161597 · HWC Screw, Fixation, Bone
Tyber Medical BioTy® Nanotopography Trauma Screw
| Applicant | Tyber Medical, LLC, Morristown NJ, US |
| Decision | Substantially Equivalent, Nov 16, 2016 |
| Received | Jun 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161597
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.