MODIFICATION TO VALEO VBR

Spinal Vertebral Body Replacement Device

AMEDICA CORP.

The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Modification To Valeo Vbr.

Pre-market Notification Details

Device IDK073505
510k NumberK073505
Device Name:MODIFICATION TO VALEO VBR
ClassificationSpinal Vertebral Body Replacement Device
Applicant AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington,  DC  20005
ContactAdam Herder
CorrespondentAdam Herder
AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington,  DC  20005
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-13
Decision Date2008-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841732129740 K073505 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.