The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Biolox Delta Ceramic Femoral Heads.
| Device ID | K051588 |
| 510k Number | K051588 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540608307 | K051588 | 000 |
| 04546540608291 | K051588 | 000 |