The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Biolox Delta Ceramic Femoral Heads.
| Device ID | K100412 |
| 510k Number | K100412 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010656735 | K100412 | 000 |
| 03596010656728 | K100412 | 000 |
| 03596010656711 | K100412 | 000 |