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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 K052607
FOIA Releasable 510(k) K052607
Device Name ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received09/22/2005
Decision Date 11/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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