The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Self-countersinking Bone Screw.
| Device ID | K013534 |
| 510k Number | K013534 |
| Device Name: | SELF-COUNTERSINKING BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2001-12-17 |
| Summary: | summary |