The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Sl-plus & Slr-plus Stems W/biolox Ceramic Heads.
| Device ID | K930963 |
| 510k Number | K930963 |
| Device Name: | SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-24 |
| Decision Date | 1994-01-07 |