510(k) K022549 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
RESTORATION MODULAR SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 23, 2002 |
| Received | Aug 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022549
| 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 |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Conical Distal Stem;
Sterile, Titanium Alloy. One unit per package.
Stryker Ireland
Carrigtwohill County Cork, Ireland.
Authorized Representative in Europe: Stryker France, Cedex Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.