The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Biolox Delta Ceramic Femoral Head.
| Device ID | K082991 |
| 510k Number | K082991 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-07 |
| Decision Date | 2008-11-20 |
| Summary: | summary |