Cleared Traditional

ZSFab Lumbar Interbody System

K221858 · Zsfab, Inc. · Orthopedic

Oct 2022

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K221858 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. (Walthan, US). The FDA issued a Cleared decision on October 14, 2022, 109 days after receiving the submission on June 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K221858 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2022
Decision Date	October 14, 2022
Days to Decision	109 days
Submission Type	Traditional
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.