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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 K121004
Device Name APEX KIRSCHNER WIRES AND STEINMANN PINS
Original Applicant
APEX TOOLS & ORTHOPEDICS CO.
1331 h street nw 12th floor
washington,  DC  20005
Original Contact hollace saas rhodes
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received04/03/2012
Decision Date 04/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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