The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mimix Mp Bone Void Filler.
| Device ID | K043280 |
| 510k Number | K043280 |
| Device Name: | MIMIX MP BONE VOID FILLER |
| Classification | Methyl Methacrylate For Cranioplasty |
| 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 | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2004-12-21 |
| Summary: | summary |