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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K100243
Device Name QUINTEX CERVICAL PLATING SYSTEM
Applicant
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Lisa Boyle
Correspondent
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Lisa Boyle
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/27/2010
Decision Date 09/02/2010
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
Recalls CDRH Recalls
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