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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 K121801
Device Name QUINTEX CERVICAL PLATING SYSTEM
Original Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley,  PA  18034
Original Contact lisa boyle
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/19/2012
Decision Date 09/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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