The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Revelation And Linear Hip Stems And Fmp Acetabular Shells (spiked, Hemispherical And Flared).
| Device ID | K072888 |
| 510k Number | K072888 |
| Device Name: | REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Tiffany Hutto |
| Correspondent | Tiffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-10 |
| Decision Date | 2008-01-10 |
| Summary: | summary |