The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for M2a/c2a Acetabular System.
| Device ID | K042841 |
| 510k Number | K042841 |
| Device Name: | M2A/C2A ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Patricia S Andborn Beres |
| Correspondent | Patricia S Andborn Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-14 |
| Decision Date | 2004-12-21 |
| Summary: | summary |