LigaPASS® Spinal System, CD Horizon™ Spinal System

Bone Fixation Cerclage, Sublaminar

Medtronic, Inc.

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

Pre-market Notification Details

Device IDK211057
510k NumberK211057
Device Name:LigaPASS® Spinal System, CD Horizon™ Spinal System
ClassificationBone Fixation Cerclage, Sublaminar
Applicant Medtronic, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactTaylor Gold West
CorrespondentShweta Sharma
Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
Product CodeOWI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeNKB
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2021-05-27

Trademark Results [LigaPASS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIGAPASS
LIGAPASS
79105527 4239786 Live/Registered
MEDICREA INTERNATIONAL
2011-09-26

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