The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Forged, Textured & Porous Stems W/biolox Ceramic Heads.
| Device ID | K955563 |
| 510k Number | K955563 |
| Device Name: | FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley Bock |
| Correspondent | Ashley Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | LPH |
| Subsequent Product Code | JDG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-06 |
| Decision Date | 1996-08-09 |
| Summary: | summary |