The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for M2a Magnum System.
| Device ID | K042037 |
| 510k Number | K042037 |
| Device Name: | M2A MAGNUM SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET, INC. 56 EAST BELL DR. 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 | 2004-07-29 |
| Decision Date | 2004-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304993570 | K042037 | 000 |
| 00880304993419 | K042037 | 000 |
| 00880304993426 | K042037 | 000 |
| 00880304993433 | K042037 | 000 |
| 00880304993440 | K042037 | 000 |
| 00880304993457 | K042037 | 000 |
| 00880304993464 | K042037 | 000 |
| 00880304993471 | K042037 | 000 |
| 00880304993488 | K042037 | 000 |
| 00880304993495 | K042037 | 000 |
| 00880304993501 | K042037 | 000 |
| 00880304993518 | K042037 | 000 |
| 00880304993525 | K042037 | 000 |
| 00880304993532 | K042037 | 000 |
| 00880304993549 | K042037 | 000 |
| 00880304993556 | K042037 | 000 |
| 00880304993563 | K042037 | 000 |
| 00880304993402 | K042037 | 000 |