510(k) K103835 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, May 5, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103835
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument.
Howmedica Osteonics Corp.
A Subsidiary of Stryker Corp.
Stry Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.