510(k) K191463 ยท JDR Staple, Fixation, Bone
DePuy Synthes Hammertoe Continuous Compression Implant
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Feb 26, 2020 |
| Received | Jun 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2022 | Synthes (USA) Products LLC DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 Open, Classified |
JDR | None listed |
| Oct 6, 2022 | Synthes (USA) Products LLC Hammertoe Continuous Compression Implant (CCI) Kit
Part Number: 46.239.001 Open, Classified |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.