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FDA 510(k)

ZSAlign Cervical Interbody System

K-Number: K261451 · 2026-07-31

ApplicantZSFab, Inc.
Decision Date2026-07-31
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZSAlign Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is ZSFab, Inc.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K261451. 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 ZSAlign Cervical Interbody System?

ZSAlign Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is ZSFab, Inc.. The 510(k) number is K261451.

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

ZSAlign Cervical Interbody System received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261451.

Who is the listed applicant for ZSAlign Cervical Interbody System?

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

What is the FDA product code for ZSAlign Cervical Interbody System?

The FDA product code for ZSAlign Cervical Interbody System is OVE.

Other records listing ZSFab, 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.

K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemK252610ZSFab Lumbar Interbody SystemK242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemK232150ZSFab Cervical Interbody SystemK221858ZSFab Lumbar Interbody SystemK202488ZSFab Cervical Interbody System

View all 7 devices →

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.

K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus 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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