510(k) K141493 ยท HRS Plate, Fixation, Bone
PROXIMAL HUMERUS PLATING SYSTEM
| Applicant | Miami Device Solutions, Pompano Beach FL, US |
| Decision | Substantially Equivalent, Mar 20, 2015 |
| Received | Jun 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2019 | Miami Device Solutions, LLC. Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractu Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.