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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 K121354
Device Name MICRO/MINI N-PK(F) BONE ANCHOR
Applicant
ANULEX TECHNOLOGIES, INC
5600 rowland road, ste 280
minnetonka,  MN  55343
Contact rachel kennedy
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/04/2012
Decision Date 11/09/2012
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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