QUANTUM VERTEBRAL BODY REPLACEMENT

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 Quantum Vertebral Body Replacement.

Pre-market Notification Details

Device IDK050449
510k NumberK050449
Device Name:QUANTUM VERTEBRAL BODY REPLACEMENT
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-22
Decision Date2005-07-07
Summary:summary

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