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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 K151068
Device Name SureLock W Suture Anchor
Applicant
CAYENNE MEDICAL, INC
16597 N 92ND STREET
SCOTTSDALE,  AZ  85260
Applicant Contact SHIMA HASHEMIAN
Correspondent
CAYENNE MEDICAL, INC
16597 N 92ND STREET., SUITE 101
SCOTTSDALE,  AZ  85260
Correspondent Contact SHIMA HASHEMIAN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/21/2015
Decision Date 07/24/2015
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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