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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 Intervertebral Body
510(k) Number K150449
Device Name LITe Plate System
Applicant
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact GARRY T. HAYECK
Correspondent
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact GARRY T. HAYECK
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/20/2015
Decision Date 03/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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