The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for M2a Acetabular System.
| Device ID | K011110 |
| 510k Number | K011110 |
| Device Name: | M2A ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley BIOMET, INC. 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 | 2001-04-11 |
| Decision Date | 2001-07-02 |