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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K142741
Device Name OASYS System
Applicant
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact Garry T Hayeck
Correspondent
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact Garry T Hayeck
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/24/2014
Decision Date 01/15/2015
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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