MODIFICATION TO: INTERPLATE VBR SYSTEM

Spinal Vertebral Body Replacement Device

RSB SPINE LLC.

The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Modification To: Interplate Vbr System.

Pre-market Notification Details

Device IDK071372
510k NumberK071372
Device Name:MODIFICATION TO: INTERPLATE VBR SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland,  OH  44026
ContactKaren Warden
CorrespondentKaren Warden
RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland,  OH  44026
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-16
Decision Date2007-06-11
Summary:summary

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