510(k) K081608 ยท HRS Plate, Fixation, Bone
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
| Applicant | Toby Orthopaedics, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Jun 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Toby Orthopaedics, Inc. PANTERA Proximal Humerus Fracture Plate System Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.