EARP Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Nvision Biomedical Technologies, Inc.

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc. with the FDA for Earp Interbody System.

Pre-market Notification Details

Device IDK212477
510k NumberK212477
Device Name:EARP Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio,  TX  78249
ContactDiana Langham
CorrespondentJeffrey Brittan
Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad,  CA  92008
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2022-04-28

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