Cleared Special

EDEN Spinal Fixation MIS System

K230762 · Jmt Co., Ltd. · Orthopedic

Jun 2023

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K230762 is an FDA 510(k) clearance for the EDEN Spinal Fixation MIS 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 15, 2023, 87 days after receiving the submission on March 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K230762 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2023
Decision Date	June 15, 2023
Days to Decision	87 days
Submission Type	Special
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.