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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K101837
Device Name ACL TIGHTROPE DOUBLE BUNDLE
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact GEENA AUGUSTINE
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent Contact GEENA AUGUSTINE
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Codes
GAP   GAT  
Date Received07/01/2010
Decision Date 12/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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