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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 Bone Graft, Cervical
510(k) Number K083311
Device Name AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
Aesculap Implant Systems, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
Aesculap AG
Am Aesculap Platz
Tuttlingen, Donau
Baden-Wurttemberg,  DK D-78532
Correspondent Contact Kathy Racosky
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/10/2008
Decision Date 03/04/2009
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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