LDR SPINE ROI-C IMPLANT

Spinal Vertebral Body Replacement Device

LDR SPINE USA

The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Roi-c Implant.

Pre-market Notification Details

Device IDK080728
510k NumberK080728
Device Name:LDR SPINE ROI-C IMPLANT
ClassificationSpinal Vertebral Body Replacement Device
Applicant LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin,  TX  78759
ContactNoah Bartsch
CorrespondentNoah Bartsch
LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin,  TX  78759
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-14
Decision Date2008-05-29
Summary:summary

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