The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Biolox Alumina Ceramic Femoral Head.
| Device ID | K981847 |
| 510k Number | K981847 |
| Device Name: | BIOLOX ALUMINA CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Joann Kuhne |
| Correspondent | Joann Kuhne SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010385383 | K981847 | 000 |
| 03596010385376 | K981847 | 000 |
| 03596010385369 | K981847 | 000 |
| 03596010385345 | K981847 | 000 |
| 03596010385338 | K981847 | 000 |