ASTRA SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

SPINECRAFT LLC

The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Astra Spine System.

Pre-market Notification Details

Device IDK150417
510k NumberK150417
Device Name:ASTRA SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SPINECRAFT LLC 777 OAKMONT LANE Westmont,  IL  60559
ContactAmi Akallal-asaad
CorrespondentAmi Akallal-asaad
SPINECRAFT LLC 777 OAKMONT LANE Westmont,  IL  60559
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-18
Decision Date2015-05-19
Summary:summary

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