The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 36mm Biolox Delta Ceramic Heads.
| Device ID | K061312 |
| 510k Number | K061312 |
| Device Name: | 36MM BIOLOX DELTA CERAMIC HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304591639 | K061312 | 000 |
| 00880304591622 | K061312 | 000 |
| 00880304591615 | K061312 | 000 |
| 00880304591608 | K061312 | 000 |
| 00887868248504 | K061312 | 000 |
| 00887868248498 | K061312 | 000 |
| 00887868248481 | K061312 | 000 |
| 00887868248474 | K061312 | 000 |