MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM

Spinal Vertebral Body Replacement Device

QUANTUM ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Quantum Orthopedics, Inc. with the FDA for Modification To Quantum Vertebral Body Replacement System.

Pre-market Notification Details

Device IDK061576
510k NumberK061576
Device Name:MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant QUANTUM ORTHOPEDICS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad,  CA  92008
ContactJason Blain
CorrespondentJason Blain
QUANTUM ORTHOPEDICS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad,  CA  92008
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-07
Decision Date2006-07-03
Summary:summary

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