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 IDK211323
510k NumberK211323
Device Name:ASTRA Spine System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont,  IL  60559
ContactAmi Akallal-asaad
CorrespondentAmi Akallal-asaad
SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont,  IL  60559
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-30
Decision Date2021-06-03

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