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FDA 510(k)

Range/Denali/Mesa Spinal System

K-Number: K171832 · 2017-09-14

ApplicantK2m, Inc.
Decision Date2017-09-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Range/Denali/Mesa Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2017-09-14 under approval number K171832. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Range/Denali/Mesa Spinal System?

Range/Denali/Mesa Spinal System is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by K2m, Inc.. The 510(k) number is K171832.

When was Range/Denali/Mesa Spinal System approved by the FDA?

Range/Denali/Mesa Spinal System received FDA 510(k) clearance on 2017-09-14, under approval number K171832.

What company makes Range/Denali/Mesa Spinal System?

Range/Denali/Mesa Spinal System is manufactured by K2m, Inc..

What is the FDA product code for Range/Denali/Mesa Spinal System?

The FDA product code for Range/Denali/Mesa Spinal System is NKB.

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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)

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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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