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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
510(k) Number K153415
Device Name Reprocessed Stryker External Fixation Devices
Applicant
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Applicant Contact KELLI DRYER
Correspondent
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Correspondent Contact KELLI DRYER
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
JEC   KTW  
Date Received11/25/2015
Decision Date 01/13/2016
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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