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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 K131769
Device Name CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
Applicant
PIVOT MEDICAL INC.
247 HUMBOLDT CT
SUNNYVALE,  CA  94089
Applicant Contact Jon Cook
Correspondent
PIVOT MEDICAL INC.
247 HUMBOLDT CT
SUNNYVALE,  CA  94089
Correspondent Contact Jon Cook
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/17/2013
Decision Date 10/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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