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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 K060491
Device Name QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Quantum Orthopedics, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Applicant Contact JASON BLAIN
Correspondent
Quantum Orthopedics, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Correspondent Contact JASON BLAIN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/24/2006
Decision Date 03/13/2006
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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