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 |