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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K083186
Device Name AESCULAP HYDROLIFT VBR SYSTEM
Applicant
Aesculap Implant System, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact MATHEW M HULL
Correspondent
Aesculap AG
Am Aesculap Platz
Tuttlingen, Donau
Baden-Wurttemberg,  DK D-78532
Correspondent Contact Kathy Racosky
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/29/2008
Decision Date 03/04/2010
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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