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FDA 510(k)

Caspian OCT/MESA Mini/DENALI Mini Spinal System

K-Number: K153370 · 2016-02-16

ApplicantK2m, Incorporated
Decision Date2016-02-16
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Caspian OCT/MESA Mini/DENALI Mini Spinal System is a medical device manufactured by K2m, Incorporated. It received FDA 510(k) clearance on 2016-02-16 under approval number K153370. 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 Caspian OCT/MESA Mini/DENALI Mini Spinal System?

Caspian OCT/MESA Mini/DENALI Mini Spinal System is a medical device that received FDA 510(k) clearance on 2016-02-16. It is manufactured by K2m, Incorporated. The 510(k) number is K153370.

When was Caspian OCT/MESA Mini/DENALI Mini Spinal System approved by the FDA?

Caspian OCT/MESA Mini/DENALI Mini Spinal System received FDA 510(k) clearance on 2016-02-16, under approval number K153370.

What company makes Caspian OCT/MESA Mini/DENALI Mini Spinal System?

Caspian OCT/MESA Mini/DENALI Mini Spinal System is manufactured by K2m, Incorporated.

What is the FDA product code for Caspian OCT/MESA Mini/DENALI Mini Spinal System?

The FDA product code for Caspian OCT/MESA Mini/DENALI Mini 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, Incorporated

K161369EVEREST Spinal System

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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