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FDA 510(k)

Zenius™ Spinal System

K-Number: K232218 · 2023-08-24

ApplicantMedyssey USA, Inc.
Decision Date2023-08-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zenius™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K232218. 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 Zenius™ Spinal System?

Zenius™ Spinal System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K232218.

When did Zenius™ Spinal System receive FDA 510(k) clearance?

Zenius™ Spinal System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K232218.

Who is the listed applicant for Zenius™ Spinal System?

The FDA 510(k) record lists Medyssey USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenius™ Spinal System?

The FDA product code for Zenius™ Spinal System is NKB.

Other records listing Medyssey USA, Inc. 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.

K230301Athena III Cervical Plate SystemK223654Medussa-PL CageK200283Medussa-PL CageK183407Triton CageK183409Athena II Cervical Plate SystemK181978Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

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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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