SPINAL USA VBR SYSTEM

Spinal Vertebral Body Replacement Device

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Vbr System.

Pre-market Notification Details

Device IDK061752
510k NumberK061752
Device Name:SPINAL USA VBR SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood,  MS  39232
ContactJeffrey Johnson
CorrespondentJeffrey Johnson
SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood,  MS  39232
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-21
Decision Date2006-08-15
Summary:summary

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