SpineNet SSP System

Appliance, Fixation, Spinal Intervertebral Body

SpineNet LLC

The following data is part of a premarket notification filed by Spinenet Llc with the FDA for Spinenet Ssp System.

Pre-market Notification Details

Device IDK200170
510k NumberK200170
Device Name:SpineNet SSP System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SpineNet LLC 1300 Minnesota Ave., Suite 200 Winter Park,  FL  32789
ContactKing Floyd
CorrespondentKaren E Warden
BackRoads Consulting PO Box 566 Chesterland,  OH  44026
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-23
Decision Date2020-02-05

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