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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 K112876
Device Name CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
Applicant
Cayenne Medical, Inc.
16597 N. 92nd St., Suite 101
Scottsdale,  AZ  85260
Applicant Contact KERESHMEH SHAHRIARI
Correspondent
Cayenne Medical, Inc.
16597 N. 92nd St., Suite 101
Scottsdale,  AZ  85260
Correspondent Contact KERESHMEH SHAHRIARI
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received09/30/2011
Decision Date 12/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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