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FDA 510(k)

Range (Denali and Mesa) Spinal Systems

K-Number: K181119 · 2018-06-26

ApplicantK2m, Inc.
Decision Date2018-06-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Range (Denali and Mesa) Spinal Systems is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2018-06-26 under approval number K181119. 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 and Mesa) Spinal Systems?

Range (Denali and Mesa) Spinal Systems is a medical device that received FDA 510(k) clearance on 2018-06-26. It is manufactured by K2m, Inc.. The 510(k) number is K181119.

When was Range (Denali and Mesa) Spinal Systems approved by the FDA?

Range (Denali and Mesa) Spinal Systems received FDA 510(k) clearance on 2018-06-26, under approval number K181119.

What company makes Range (Denali and Mesa) Spinal Systems?

Range (Denali and Mesa) Spinal Systems is manufactured by K2m, Inc..

What is the FDA product code for Range (Denali and Mesa) Spinal Systems?

The FDA product code for Range (Denali and Mesa) Spinal Systems is NKB.

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Related PubMed Literature

PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026) PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025) PMID: 40070372 Dissemination strategies of clinical practice guidelines-mixed methods evidence synthesis protocol. Clinical and public health guidelines (2025)

Other Devices by K2m, Inc.

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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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