510(k) K202589 ยท HWC Screw, Fixation, Bone
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
| Applicant | Medartis AG, Basel, CH |
| Decision | Substantially Equivalent, Nov 6, 2020 |
| Received | Sep 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2026 | Medartis AG Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.