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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K062004
Device Name MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
Applicant
Quantum Orthopedics, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Applicant Contact KERRI DIMARTINO
Correspondent
Quantum Orthopedics, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Correspondent Contact KERRI DIMARTINO
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/17/2006
Decision Date 08/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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