510(k) K904973

EXTERNAL FIXATION by Dynasplint Systems, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
October 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type