The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for M2a Magnum 12/14 Taper Inserts And One-piece Modular Heads.
| Device ID | K061423 |
| 510k Number | K061423 |
| Device Name: | M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-23 |
| Decision Date | 2006-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304537392 | K061423 | 000 |
| 00880304647336 | K061423 | 000 |
| 00880304647312 | K061423 | 000 |
| 00880304647299 | K061423 | 000 |
| 00880304647275 | K061423 | 000 |
| 00880304647268 | K061423 | 000 |
| 00880304476936 | K061423 | 000 |
| 00887868462993 | K061423 | 000 |