Healix Compression Screw System

Screw, Fixation, Bone

Nvision Biomedical Technologies, Inc

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

Pre-market Notification Details

Device IDK200914
510k NumberK200914
Device Name:Healix Compression Screw System
ClassificationScrew, Fixation, Bone
Applicant Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio,  TX  78249
ContactDiana Langham
CorrespondentJeffrey Brittan
Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad,  CA  92008
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-05-05

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