Cleared Special

ZSFab Lumbar Interbody System

K252610 · Zsfab, Inc. · Orthopedic

Nov 2025

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K252610 is an FDA 510(k) clearance for the ZSFab Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Zsfab, Inc. (Waltham, US). The FDA issued a Cleared decision on November 25, 2025, 99 days after receiving the submission on August 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K252610 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2025
Decision Date	November 25, 2025
Days to Decision	99 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.