The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Fmp Coated Spiked Acetabular Cup; Hemispherical Acetabular Cup; Flared Rim Acetabular Cup; Metal/metal Acetabular Insert.
| Device ID | K063257 |
| 510k Number | K063257 |
| Device Name: | FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-27 |
| Decision Date | 2006-11-22 |
| Summary: | summary |