Cleared Traditional

Cannulated Power Driver Attachment

K202528 · K2m, Inc. · Orthopedic

Oct 2020

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K202528 is an FDA 510(k) clearance for the Cannulated Power Driver Attachment, 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 October 26, 2020, 55 days after receiving the submission on September 1, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K202528 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2020
Decision Date	October 26, 2020
Days to Decision	55 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.