510(k) K961157

WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW by Whiteside Biomechanics, Inc. — Product Code HWC

K961157 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW". The FDA issued a decision of SN on May 17, 1996. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 17, 1996
Date Received
March 22, 1996
Clearance Type
Traditional
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