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FDA 510(k)

YUKON OCT Spinal System

K-Number: K171444 · 2017-08-08

ApplicantK2m, Inc.
Decision Date2017-08-08
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

YUKON OCT Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2017-08-08 under approval number K171444. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YUKON OCT Spinal System?

YUKON OCT Spinal System is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by K2m, Inc.. The 510(k) number is K171444.

When was YUKON OCT Spinal System approved by the FDA?

YUKON OCT Spinal System received FDA 510(k) clearance on 2017-08-08, under approval number K171444.

What company makes YUKON OCT Spinal System?

YUKON OCT Spinal System is manufactured by K2m, Inc..

What is the FDA product code for YUKON OCT Spinal System?

The FDA product code for YUKON OCT Spinal System is NKG.

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 K2m, Inc.

K162664Pyrenees Cervical Plate System K162264Cascadia Interbody System K161028K2M Growing Spine System K160208NILE Alternative Fixation Spinal System K172009Cascadia Interbody System K171832Range/Denali/Mesa Spinal System

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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