APEX-DL 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 Apex-dl Spine System.

Pre-market Notification Details

Device IDK143683
510k NumberK143683
Device Name:APEX-DL 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 CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-24
Decision Date2015-05-22
Summary:summary

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