The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Fmp Metal/metal Acetabular Insert, 499-28,449-34, 499-38.
| Device ID | K070221 |
| 510k Number | K070221 |
| Device Name: | FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-04-04 |
| Summary: | summary |