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FDA 510(k)

NeckTune™ 3D SA Cervical Cage

K-Number: K260036 · 2026-06-15

ApplicantMedyssey Co, Ltd.
Decision Date2026-06-15
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NeckTune™ 3D SA Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260036. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeckTune™ 3D SA Cervical Cage?

NeckTune™ 3D SA Cervical Cage is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K260036.

When did NeckTune™ 3D SA Cervical Cage receive FDA 510(k) clearance?

NeckTune™ 3D SA Cervical Cage received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260036.

Who is the listed applicant for NeckTune™ 3D SA Cervical Cage?

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

What is the FDA product code for NeckTune™ 3D SA Cervical Cage?

The FDA product code for NeckTune™ 3D SA Cervical Cage is OVE.

Other records listing Medyssey 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.

K242806Medyssey Navigation System

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260660SABER-C SystemElevation SpineK253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.

Official Source

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

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