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FDA 510(k)

EDEN Spinal Fixation MIS System

K-Number: K230762 · 2023-06-15

ApplicantJmt Co., Ltd.
Decision Date2023-06-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDEN Spinal Fixation MIS System is a medical device manufactured by Jmt Co., Ltd.. It received FDA 510(k) clearance on 2023-06-15 under approval number K230762. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDEN Spinal Fixation MIS System?

EDEN Spinal Fixation MIS System is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Jmt Co., Ltd.. The 510(k) number is K230762.

When was EDEN Spinal Fixation MIS System approved by the FDA?

EDEN Spinal Fixation MIS System received FDA 510(k) clearance on 2023-06-15, under approval number K230762.

What company makes EDEN Spinal Fixation MIS System?

EDEN Spinal Fixation MIS System is manufactured by Jmt Co., Ltd..

What is the FDA product code for EDEN Spinal Fixation MIS System?

The FDA product code for EDEN Spinal Fixation MIS System is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Jmt Co., Ltd.

K201793EDEN Peek Cage K201788EDEN Spinal Fixation System K241410EDEN ControlCath

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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