510(k) K141232 ยท HRS Plate, Fixation, Bone
APTUS ULNA SHORTENING 2.5
| Applicant | Medartis AG, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 23, 2014 |
| Received | May 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2014 | Medartis, Inc. APTUS Ulna Shortening 2.5
Product Usage:
APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.