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FDA 510(k)

Zenius Spinal System

K-Number: K170964 · 2017-04-26

ApplicantMedyssey USA, Inc.
Decision Date2017-04-26
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 2017-04-26 under 510(k) number K170964. 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 2017-04-26. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K170964.

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

Zenius Spinal System received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170964.

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

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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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