510(k) K113384

EXTERNAL FIXATOR ST.A R 90 F4 by Citieffe — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2012
Date Received
November 16, 2011
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