The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Cannulated Screw System.
| Device ID | K140891 |
| 510k Number | K140891 |
| Device Name: | BIOMET CANNULATED SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Victoria Scheitlin |
| Correspondent | Victoria Scheitlin BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-08 |
| Decision Date | 2014-06-03 |
| Summary: | summary |