BIOSPINE VBR SYSTEM

Spinal Vertebral Body Replacement Device

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Biospine Vbr System.

Pre-market Notification Details

Device IDK110864
510k NumberK110864
Device Name:BIOSPINE VBR SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa Boyle
CorrespondentLisa Boyle
AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-29
Decision Date2011-06-15
Summary:summary

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