The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Zirconia Ceramic Femoral Heads With Foundation Forged, Textured And Porous Stems, The Encore Vitality Stems And Sl And.
| Device ID | K965002 |
| 510k Number | K965002 |
| Device Name: | ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-06-27 |
| Summary: | summary |