The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Metal/metal Hip System.
| Device ID | K040354 |
| 510k Number | K040354 |
| Device Name: | METAL/METAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-12 |
| Decision Date | 2004-11-04 |
| Summary: | summary |