The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for M2a 32mm Taper System.
| Device ID | K003363 |
| 510k Number | K003363 |
| Device Name: | M2A 32MM TAPER SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-27 |
| Decision Date | 2000-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304237766 | K003363 | 000 |
| 00880304209237 | K003363 | 000 |
| 00880304209244 | K003363 | 000 |
| 00880304209251 | K003363 | 000 |
| 00880304209268 | K003363 | 000 |
| 00880304209275 | K003363 | 000 |
| 00880304209282 | K003363 | 000 |
| 00880304237438 | K003363 | 000 |
| 00880304237445 | K003363 | 000 |
| 00880304237452 | K003363 | 000 |
| 00880304237759 | K003363 | 000 |
| 00880304209220 | K003363 | 000 |