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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K120493
Device Name MINI CANNULATED HEADED AND HEADLESS SCREW SET
Original Applicant
INSTRATEK, INC.
15200 middlebrook dr ste g
houston,  TX  77058
Original Contact jeff seavey
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/17/2012
Decision Date 05/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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