The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Craniofacial Anchors.
| Device ID | K974136 |
| 510k Number | K974136 |
| Device Name: | CRANIOFACIAL ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| Subsequent Product Code | GAN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-01-30 |
| Summary: | summary |