510(k) K102019 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
RESTORATION ACETABULAR WEDGE AUGMENTS
| Applicant | Howmedica Osteonics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Mar 3, 2011 |
| Received | Jul 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
Hip prosthesis component. The RESTORATION Acet Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.