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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 K181083
Device Name Stryker All-PEEK Knotless Anchor System
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Katie Farraro
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Katie Farraro
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/24/2018
Decision Date 07/23/2018
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
Recalls CDRH Recalls
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