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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 K150443
Device Name ToeTac Hammertoe Fixation System
Applicant
Restore Surgical, LLC Dba Instratek
15200 Middlebrook Dr., Suite G
Houston,  TX  77058
Applicant Contact JEFF SEAVEY
Correspondent
Restore Surgical, LLC Dba Instratek
15200 Middlebrook Dr., Suite G
Houston,  TX  77058
Correspondent Contact JEFF SEAVEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/20/2015
Decision Date 06/04/2015
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
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