Cleared Traditional

K261451 - ZSAlign Cervical Interbody System

K261451 is an FDA 510(k) clearance for ZSAlign Cervical Interbody System, manufactured by Zsfab, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K261451 · Zsfab, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
91d
Days
Class 2
Risk

K261451 is an FDA 510(k) clearance for the ZSAlign Cervical Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Zsfab, Inc. (Waltham, US). The FDA issued a Cleared decision on July 31, 2026 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zsfab, Inc. devices

FDA 510(k) Submission Details - K261451

510(k) Number K261451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2026
Decision Date July 31, 2026
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

ATS Colorado Springs
Hannah Taggart

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K261451.
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