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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 K112675
Device Name ARROW-LOK DIGITAL SYSTEM
Applicant
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
328 POPLAR VIEW LANE EAST
SUITE 2
COLLIERVILLE,  TN  38017
Applicant Contact THOMAS J TWARDZIK
Correspondent
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
328 POPLAR VIEW LANE EAST
SUITE 2
COLLIERVILLE,  TN  38017
Correspondent Contact THOMAS J TWARDZIK
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/14/2011
Decision Date 12/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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