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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K972233
Device Name STRYKER WEDGE INTERFERENCE SCREW SYSTEM
Applicant
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Applicant Contact DOUGLAS M LORANG
Correspondent
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Correspondent Contact DOUGLAS M LORANG
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/16/1997
Decision Date 08/05/1997
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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