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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 K102057
Device Name TARGON FN SYSTEM
Applicant
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/22/2010
Decision Date 12/21/2010
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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