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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
Applicant Contact RACHEL KENNEDY
Correspondent
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Correspondent Contact RACHEL KENNEDY
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/04/2012
Decision Date 11/09/2012
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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