The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biolox Delta Option Ceramic Heads.
| Device ID | K082996 |
| 510k Number | K082996 |
| Device Name: | BIOLOX DELTA OPTION 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 | 2008-10-08 |
| Decision Date | 2009-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304521964 | K082996 | 000 |
| 00887868248689 | K082996 | 000 |
| 00887868248672 | K082996 | 000 |
| 00887868248665 | K082996 | 000 |
| 00887868248658 | K082996 | 000 |
| 00887868248641 | K082996 | 000 |
| 00887868248634 | K082996 | 000 |
| 00887868248627 | K082996 | 000 |
| 00887868248610 | K082996 | 000 |
| 00887868248597 | K082996 | 000 |
| 00887868248580 | K082996 | 000 |
| 00887868248573 | K082996 | 000 |
| 00887868248696 | K082996 | 000 |
| 05019279354191 | K082996 | 000 |
| 00880304521957 | K082996 | 000 |
| 00880304521940 | K082996 | 000 |
| 00880304521933 | K082996 | 000 |
| 00880304521926 | K082996 | 000 |
| 00880304521919 | K082996 | 000 |
| 00880304521902 | K082996 | 000 |
| 00880304521896 | K082996 | 000 |
| 00880304520158 | K082996 | 000 |
| 05019279354252 | K082996 | 000 |
| 05019279354238 | K082996 | 000 |
| 05019279354214 | K082996 | 000 |
| 00887868248566 | K082996 | 000 |