The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Hip Stems With Ceramic Heads And Uhmwpe Liners.
| Device ID | K082398 |
| 510k Number | K082398 |
| Device Name: | ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-20 |
| Decision Date | 2008-10-15 |
| Summary: | summary |