DeviceClearance

ZSAlign Cervical Interbody System— 510(k) K261451

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.

Summary

ZSFab's ZSAlign Cervical Interbody System is filed under OVE, cervical intervertebral fusion devices with integrated fixation. The record doesn't give sizes or materials.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

ZSFab filed from Waltham, Massachusetts. Review took 91 calendar days (May 1 to July 31, 2026).

Clearance details

Applicant
ZSFab, Inc.
Product code
Product code OVE
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OVE

product code OVE
Injury
293
Malfunction
710
Total
1,003

Source: openFDA MAUDE database, through . 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.