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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 K133802
Device Name AIS MODULIFT VBR SYSTEM
Applicant
Aesculap Implant System, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
Aesculap Implant System, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Correspondent Contact LISA M BOYLE
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/13/2013
Decision Date 04/17/2014
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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