510(k) K993903

WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 by Whiteside Biomechanics, Inc. — Product Code JDQ

K993903 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013". The FDA issued a decision of Substantially Equivalent on February 14, 2000. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2000
Date Received
November 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type