510(k) K024086

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM by Biomet Orthopedics, Inc. — Product Code HWC

K024086 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 2003. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2003
Date Received
December 11, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type