The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Reliance Pf Femoral Stems.
| Device ID | K970200 |
| 510k Number | K970200 |
| Device Name: | RELIANCE PF FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-09 |
| Summary: | summary |