Boundary Anterior Lumbar Buttress Plate

Appliance, Fixation, Spinal Intervertebral Body

Nvision Biomedical Technologies, LLC

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Boundary Anterior Lumbar Buttress Plate.

Pre-market Notification Details

Device IDK173091
510k NumberK173091
Device Name:Boundary Anterior Lumbar Buttress Plate
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103 San Antonio,  TX  78232
ContactDiana L. Langham
CorrespondentAllison C. Komiyama, Ph.d., R.a.c.
AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego,  CA  92104
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-12-06
Summary:summary

NIH GUDID Devices

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