Cleared Traditional

EDEN Spinal Fixation System

K201788 · Jmt Co., Ltd. · Orthopedic

Jun 2022

Decision

723d

Days

Class 2

Risk

About This 510(k) Submission

K201788 is an FDA 510(k) clearance for the EDEN Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Jmt Co., Ltd. (Yangju-Si, KR). The FDA issued a Cleared decision on June 23, 2022, 723 days after receiving the submission on June 30, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K201788 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2020
Decision Date	June 23, 2022
Days to Decision	723 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.