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EDEN Spinal Fixation MIS System

by Jmt Co., Ltd.

510(k) K230762

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK230762 Date15 Jun 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EDEN Spinal Fixation MIS System is a thoracolumbosacral pedicle screw system intended for spinal fixation. It is a medical device manufactured by Jmt Co., Ltd.

The device received FDA 510(k) clearance on 2023-06-15 under K230762 and is classified as Class II with product code NKB. It is supplied as a non-sterile, reusable system for use in orthopedic surgical settings.

Other devices from Jmt Co., Ltd.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EDEN Spinal Fixation MIS System intended for?

    The EDEN Spinal Fixation MIS System is intended for spinal fixation as a thoracolumbosacral pedicle screw system, used in orthopedic surgical settings to stabilize the spine during procedures.

  • How is the EDEN Spinal Fixation MIS System supplied and is it reusable?

    The device is supplied as a non-sterile, reusable system, meaning it must be cleaned and sterilized by the healthcare facility before each use and can be used multiple times following proper reprocessing protocols.

  • What regulatory pathway was used for the EDEN Spinal Fixation MIS System?

    The EDEN Spinal Fixation MIS System received FDA 510(k) clearance on June 15, 2023, under submission number K230762, demonstrating it is substantially equivalent to a legally marketed predicate device.