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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 K172186
Device Name BioWick X Implant with Driver
Applicant
Cayenne Medical, Inc.
16597 N. 92nd Street, Suite 101
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 Received07/20/2017
Decision Date 10/16/2017
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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