510(k) K013935 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Dec 13, 2001 |
| Received | Nov 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013935
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.