510(k) K091479 ยท HRS Plate, Fixation, Bone
APTUS FOOT SYSTEM
| Applicant | Medartis AG, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 13, 2009 |
| Received | May 19, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2026 | Medartis AG Brand Name: APTUS
Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg
Model/Catalog Number: A-5850.16/1
Software Version: Not applicable.
Product Description: The APTUS fixation systems are used for frac Open, Classified |
HWC | None listed |
| May 14, 2024 | Medartis Inc. APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system. Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.