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FDA 510(k)

DeltaNEC Interbody System

K-Number: K261279 · 2026-06-22

ApplicantNexus Spine
Decision Date2026-06-22
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DeltaNEC Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nexus Spine. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K261279. 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 DeltaNEC Interbody System?

DeltaNEC Interbody System is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Nexus Spine. The 510(k) number is K261279.

When did DeltaNEC Interbody System receive FDA 510(k) clearance?

DeltaNEC Interbody System received FDA 510(k) clearance on 2026-06-22, under 510(k) number K261279.

Who is the listed applicant for DeltaNEC Interbody System?

The FDA 510(k) record lists Nexus Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeltaNEC Interbody System?

The FDA product code for DeltaNEC Interbody System is OVE.

Other records listing Nexus Spine 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.

K253331PressON Spinal Fixation SystemK243934Stable-L Lumbar Interbody SystemK241467Stable-C Interbody SystemK233375Tranquil-L Interbody SystemK240416Tranquil-C Interbody SystemK233234PressON Spinal Fixation System

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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 SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation SpineK253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices 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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