ChoiceSpine Navigation System

Orthopedic Stereotaxic Instrument

ChoiceSpine, LLC

The following data is part of a premarket notification filed by Choicespine, Llc with the FDA for Choicespine Navigation System.

Pre-market Notification Details

Device IDK220024
510k NumberK220024
Device Name:ChoiceSpine Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant ChoiceSpine, LLC 400 Erin Drive Knoxville,  TN  37919
ContactKim Finch
CorrespondentKim Finch
ChoiceSpine, LLC 400 Erin Drive Knoxville,  TN  37919
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-07-06

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