510(k) K062113 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
SOLAR REUNION FRACTURE STEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 3, 2006 |
| Received | Jul 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2007 | Stryker Howmedica Osteonics Corp. ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis.
Distal Diameter - 7 to 15mm;
Hydroxylapatite coated;
Titanium Plasma Spray;
Howmedica Osteonics Corp. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.