The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Zirconia Ceramic Modular Head 9type Ii Taper.
| Device ID | K915641 |
| 510k Number | K915641 |
| Device Name: | ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK 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 | 1991-12-17 |
| Decision Date | 1992-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304255319 | K915641 | 000 |
| 00880304255302 | K915641 | 000 |
| 00880304255296 | K915641 | 000 |
| 00880304255289 | K915641 | 000 |
| 00880304001473 | K915641 | 000 |
| 00880304001060 | K915641 | 000 |
| 00880304000995 | K915641 | 000 |