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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, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K031959
Device Name STRYKER PLATING SYSTEM PERIARTICULAR PLATES
Applicant
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Applicant Contact VIVIAN KELLY
Correspondent
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Correspondent Contact VIVIAN KELLY
Regulation Number888.3030
Classification Product Code
LXT  
Date Received06/25/2003
Decision Date 07/25/2003
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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