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Range/Denali/Mesa Spinal System

by K2m, Incorporated 510(k)

Active United States

510(k) K153031

Overview

The Range/Denali/Mesa Spinal System is a top-loading, posterior thoracic-lumbar spinal fixation system that includes pedicle screws, rods, hooks, and rod connectors. It provides immobilization and stabilization of the spine as an adjunct to fusion.

The system is supplied as a sterile device and is intended for use in posterior spinal fixation procedures. It is authorized under FDA 510(k) clearance with product code NKB and is manufactured by K2m, Incorporated.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK153031 Date17 Nov 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from K2m, Incorporated

Questions

  • What is the RANGE/DENALI/MESA Spinal System used for?

    The RANGE/DENALI/MESA Spinal System is a top-loading, posterior thoracic-lumbar spinal fixation system that provides immobilization and stabilization of the spine as an adjunct to fusion in posterior spinal fixation procedures.

  • How is the RANGE/DENALI/MESA Spinal System supplied?

    The system is supplied as a sterile device and includes pedicle screws, rods, hooks, and rod connectors to complete the posterior spinal fixation system.

  • What is the regulatory status of the RANGE/DENALI/MESA Spinal System?

    The system is authorized under FDA 510(k) clearance with product code NKB, received on October 19, 2015, and determined to be substantially equivalent by the Orthopedic advisory committee.

  • Is the RANGE/DENALI/MESA Spinal System reusable or single-use?

    The device is supplied as a sterile system, but the description does not specify whether it is designed for single-use or multiple uses, which would typically be determined by the manufacturer's instructions for use.