The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Gmrs Press Fit Stems With Purefix Ha.
| Device ID | K031217 |
| 510k Number | K031217 |
| Device Name: | GMRS PRESS FIT STEMS WITH PUREFIX HA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-05-23 |
| Summary: | summary |