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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K150539
Device Name OASYS System
Applicant
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401 -1677
Applicant Contact GARRY T. HAYECK
Correspondent
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401 -1677
Correspondent Contact GARRY T. HAYECK
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received03/03/2015
Decision Date 05/12/2015
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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