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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K122437
Models 904428, 904530 TO 904570 (BY 5), 904630 TO 904660 (BY 2), 908434,908469,908468
Device Name NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
Original Applicant
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact elizabeth wray
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received08/10/2012
Decision Date 10/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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