510(k) K190970 · HWC Screw, Fixation, Bone
PROSTEP TBI (Tailors Bunion Implant) System
| Applicant | Wrightmedicaltechnologyinc, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 13, 2019 |
| Received | Apr 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190970
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.