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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 K132244
Device Name N-FORCE FIXATION SYSTEM
Applicant
Innovision, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact MICHELLE MCDONOUGH
Correspondent
Innovision, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/18/2013
Decision Date 03/06/2014
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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