GMA 2.0 Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Grafton Medical Alliance

The following data is part of a premarket notification filed by Grafton Medical Alliance with the FDA for Gma 2.0 Pedicle Screw System.

Pre-market Notification Details

Device IDK192915
501k NumberK192915
Device Name:GMA 2.0 Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Grafton Medical Alliance 7416 Country Line Road Suite E Burr Ridge,  IL  60527
ContactJames Henry
CorrespondentCassie Sopko
JALEX Medical 27865 Clemens Rd Suite 3 Westlake,  OH  44145
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2019-11-13

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