The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Howmedica Osteonics Zirconia-toughened-alumina (biolox Delta) Ceramic Femoral Heads.
| Device ID | K041940 |
| 510k Number | K041940 |
| Device Name: | HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (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 | Terry Sheridan Powell |
| Correspondent | Terry Sheridan Powell HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154187331 | K041940 | 000 |
| 07613154166534 | K041940 | 000 |
| 07613154166541 | K041940 | 000 |
| 07613154187256 | K041940 | 000 |
| 07613154187263 | K041940 | 000 |
| 07613154187270 | K041940 | 000 |
| 07613154187287 | K041940 | 000 |
| 07613154187294 | K041940 | 000 |
| 07613154187300 | K041940 | 000 |
| 07613154187317 | K041940 | 000 |
| 07613154187324 | K041940 | 000 |
| 07613154166527 | K041940 | 000 |