Cleared Traditional

K2M Patient Specific Rods

K180376 · K2m, Inc. · Orthopedic

Apr 2018

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K180376 is an FDA 510(k) clearance for the K2M Patient Specific Rods, 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 April 5, 2018, 52 days after receiving the submission on February 12, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K180376 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2018
Decision Date	April 05, 2018
Days to Decision	52 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.