The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biolox Delta Ceramic Heads.
| Device ID | K042091 |
| 510k Number | K042091 |
| Device Name: | BIOLOX DELTA CERAMIC HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2005-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304591585 | K042091 | 000 |
| 00887868248412 | K042091 | 000 |
| 00887868248429 | K042091 | 000 |
| 00887868248436 | K042091 | 000 |
| 00887868248443 | K042091 | 000 |
| 00887868248450 | K042091 | 000 |
| 00887868248467 | K042091 | 000 |
| 00880304434035 | K042091 | 000 |
| 00880304437548 | K042091 | 000 |
| 00880304438392 | K042091 | 000 |
| 00880304438538 | K042091 | 000 |
| 00880304438804 | K042091 | 000 |
| 00880304448827 | K042091 | 000 |
| 00887868248405 | K042091 | 000 |