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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K013775
Device Name TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
Original Applicant
STRYKER LEIBINGER
4100 east milham ave.
kalamazoo,  MI  49001
Original Contact robin l rowe
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/13/2001
Decision Date 01/08/2002
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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