Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Black Box Medical LLC

The following data is part of a premarket notification filed by Black Box Medical Llc with the FDA for Pedicle Screw System.

Pre-market Notification Details

Device IDK201751
510k NumberK201751
Device Name:Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Black Box Medical LLC 4516 East County Road 45 Midland,  TX  79705
ContactTodd Stanaford
CorrespondentDaniel Lanois
SurgOp Support LLC 101 Lamond Ct Prosper,  TX  75078
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-26
Decision Date2020-07-22

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