Cleared Traditional

Range/Denali/Mesa Spinal System

K171832 · K2m, Inc. · Orthopedic

Sep 2017

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K171832 is an FDA 510(k) clearance for the Range/Denali/Mesa Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on September 14, 2017, 86 days after receiving the submission on June 20, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K171832 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2017
Decision Date	September 14, 2017
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.