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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
Applicant
Instratek, Inc.
15200 Middlebrook Dr., Suite G
Houston,  TX  77058
Applicant Contact Jeff Seavey
Correspondent
Instratek, Inc.
15200 Middlebrook Dr., Suite G
Houston,  TX  77058
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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