510(k) K061677 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
SOLAR PUREFIX HA SHOULDER
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 10, 2006 |
| Received | Jun 15, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2008 | Stryker Howmedica Osteonics Corp. Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.