510(k) K994366 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
| Applicant | Howmedica Osteonics Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Mar 16, 2000 |
| Received | Dec 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2013 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the hea Terminated |
MEH | None listed |
| Oct 20, 2011 | Stryker Howmedica Osteonics Corp. Total Hip Joint Replacement
Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3
Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430
A s Terminated |
MEH | None listed |
| Jun 13, 2011 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem:
Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5
Catalog #6020-3535 Accolade 132 Size 3.5
Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2
Catalog # 6021-0335 Acco Terminated |
ISL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.