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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K150416
Device Name ProCinch Adjustable Loop Device
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact KELLY KUCHARCZYK
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact KELLY KUCHARCZYK
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/18/2015
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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