CD Horizon Spinal System

Orthopedic Stereotaxic Instrument

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Cd Horizon Spinal System.

Pre-market Notification Details

Device IDK211596
510k NumberK211596
Device Name:CD Horizon Spinal System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic 1800 Pyramid Place Memphis,  TN  38132
ContactDiamond Wallace
CorrespondentDiamond Wallace
Medtronic 1800 Pyramid Place Memphis,  TN  38132
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-06-23

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