VALEO PEDICLE SCREW SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

AMEDICA CORP.

The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo Pedicle Screw Spinal System.

Pre-market Notification Details

Device IDK072022
510k NumberK072022
Device Name:VALEO PEDICLE SCREW SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington,  DC  20005
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-23
Decision Date2007-11-19
Summary:summary

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