510(k) K112556 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Sep 28, 2011 |
| Received | Sep 2, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2012 | Stryker Howmedica Osteonics Corp. Duration packaging distributed by
Stryker Orthopaedics, Limerick, Ireland
Stryker Ireland
Carrigtwohill Industrial Estate
Carrigtwohill County Cork, Ireland
Product Usage:
Orthopaedic implants utiliz Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.