The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Propeller Head Small Cannulated Screw System.
| Device ID | K024086 |
| 510k Number | K024086 |
| Device Name: | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-11 |
| Decision Date | 2003-01-09 |
| Summary: | summary |