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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 K100802
Device Name AESCULAP IMPLANT SYSTEMS SIBD 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 Received03/22/2010
Decision Date 07/20/2010
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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