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FDA 510(k)

EDEN Spinal Fixation System

K-Number: K201788 · 2022-06-23

ApplicantJmt Co., Ltd.
Decision Date2022-06-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDEN Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Jmt Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K201788. 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 System?

EDEN Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Jmt Co., Ltd.. The 510(k) number is K201788.

When did EDEN Spinal Fixation System receive FDA 510(k) clearance?

EDEN Spinal Fixation System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K201788.

Who is the listed applicant for EDEN Spinal Fixation System?

The FDA 510(k) record lists Jmt Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Jmt Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241410EDEN ControlCathK230762EDEN Spinal Fixation MIS SystemK201793EDEN Peek Cage

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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