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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 K151314
Device Name CinchLock Flex Knotless Suture Anchor
Applicant
Pivot Medical
247 Humboldt Court
Sunnyvale,  CA  94089
Applicant Contact Kelly Kucharczyk
Correspondent
Pivot Medical
247 Humboldt Court
Sunnyvale,  CA  94089
Correspondent Contact Kelly Kucharczyk
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/18/2015
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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