510(k) K040734 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MODIFICATION TO RESTORATION MODULAR SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 25, 2004 |
| Received | Mar 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Modular Cone Body Trials
Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland.
The Cone Body Trials simulate the respective Cone Body i Terminated |
LZO | None listed |
| May 21, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325.
Howmedica Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.