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FDA 510(k)

LigaPASS® Spinal System, CD Horizon™ Spinal System

K-Number: K211057 · 2021-05-27

ApplicantMedtronic, Inc.
Decision Date2021-05-27
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LigaPASS® Spinal System, CD Horizon™ Spinal System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2021-05-27 under approval number K211057. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LigaPASS® Spinal System, CD Horizon™ Spinal System?

LigaPASS® Spinal System, CD Horizon™ Spinal System is a medical device that received FDA 510(k) clearance on 2021-05-27. It is manufactured by Medtronic, Inc.. The 510(k) number is K211057.

When was LigaPASS® Spinal System, CD Horizon™ Spinal System approved by the FDA?

LigaPASS® Spinal System, CD Horizon™ Spinal System received FDA 510(k) clearance on 2021-05-27, under approval number K211057.

What company makes LigaPASS® Spinal System, CD Horizon™ Spinal System?

LigaPASS® Spinal System, CD Horizon™ Spinal System is manufactured by Medtronic, Inc..

What is the FDA product code for LigaPASS® Spinal System, CD Horizon™ Spinal System?

The FDA product code for LigaPASS® Spinal System, CD Horizon™ Spinal System is OWI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Medtronic, Inc.

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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