Nvc

Intervertebral Fusion Device With Bone Graft, Cervical

Nvision Biomedical Technologies, Inc.

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

Pre-market Notification Details

Device IDK190380
510k NumberK190380
Device Name:Nvc
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio,  TX  78249
ContactDiana Langham
CorrespondentJeffrey Brittan
Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad,  CA  92008
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-19
Decision Date2019-03-21
Summary:summary

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