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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 K983557
Device Name STRYKER WEDGE SUTURE ANCHOR
Applicant
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Applicant Contact TODD MILLER
Correspondent
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Correspondent Contact TODD MILLER
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
GAT  
Date Received10/13/1998
Decision Date 12/18/1998
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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