Fixxsure Anterior Lumbar Plate And Screw System

Appliance, Fixation, Spinal Intervertebral Body

Oak Tree Engineering, LLC.

The following data is part of a premarket notification filed by Oak Tree Engineering, Llc. with the FDA for Fixxsure Anterior Lumbar Plate And Screw System.

Pre-market Notification Details

Device IDK211932
510k NumberK211932
Device Name:Fixxsure Anterior Lumbar Plate And Screw System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Oak Tree Engineering, LLC. 419 Main Street, #242 Huntington Beach,  CA  92648
ContactDouglas W Neary
CorrespondentDouglas W Neary
Consultant 419 Main Street, #242, Huntington Beach,  CA  92648
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-22
Decision Date2021-07-27

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