Universal Pilot Guidance Instrument System

Orthopedic Stereotaxic Instrument

CTL Medical Corporation

The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Universal Pilot Guidance Instrument System.

Pre-market Notification Details

Device IDK213491
510k NumberK213491
Device Name:Universal Pilot Guidance Instrument System
ClassificationOrthopedic Stereotaxic Instrument
Applicant CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison,  TX  75001
ContactSean Suh
CorrespondentDhaval Saraiya
Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington,  DC  20003
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-01
Decision Date2022-05-12

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