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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K111122
Device Name AESCULAP SIBD XP SPINAL SYSTEM
Applicant
Aesculap Implant Systems, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
Aesculap Implant Systems, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Correspondent Contact LISA M BOYLE
Regulation Number888.3080
Classification Product Code
OVD  
Date Received04/21/2011
Decision Date 08/04/2011
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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