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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 K110445
Device Name FLEXFUSION (TM) FIXATION IMPLANT
Applicant
NEXTREMITY SOLUTIONS, LLC
167 STONE HILL ROAD
COLTS NECK,  NJ  07722
Applicant Contact ARTHUR A ALFARO
Correspondent
NEXTREMITY SOLUTIONS, LLC
167 STONE HILL ROAD
COLTS NECK,  NJ  07722
Correspondent Contact ARTHUR A ALFARO
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/16/2011
Decision Date 03/17/2011
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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