ZSAlign Cervical Interbody System— 510(k) K261451

Name: FDA 510(k) clearance K261451
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

ZSFab, Inc.

FDA 510(k) clearance K261451 for ZSAlign Cervical Interbody System, Substantially Equivalent on 2026-07-31. Applicant: ZSFab, Inc.. Device class: 2.

Clearance details

Applicant: ZSFab, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-05-01
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18
K260036 — NeckTune 3D SA Cervical Cage2026-06-15

More clearances from ZSFab, Inc.

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K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System2026-04-24
K252610 — ZSFab Lumbar Interbody System2025-11-25
K232150 — ZSFab Cervical Interbody System2023-08-18
K221858 — ZSFab Lumbar Interbody System2022-10-14
K202488 — ZSFab Cervical Interbody System2021-01-07

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.