510(k) K062498 ยท HRS Plate, Fixation, Bone
PROFYLE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 25, 2006 |
| Received | Aug 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Stryker Howmedica Osteonics Corp. S T-Bone Plate;
M T-Compression Plate;
Manufactured and Distributed by Stryker Lebinger GmbH & Co.
Freiburg, Germany.
The Profyle System is intended for use in internal fixation of the bones of hand a Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.