510(k) K014199 ยท LOD Bone Cement
SURGICAL SIMPLEX P WITH TOBRAMYCIN
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, May 6, 2003 |
| Received | Dec 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2022 | Howmedica Osteonics Corp. Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic
Catalog Number:6197-1-001 Open, Classified |
LOD | None listed |
| Jan 10, 2007 | Stryker Howmedica Osteonics Corp. Simplex P with Tobramycin. Antibiotic PMMA Bone Cement. Terminated |
MBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.