Cleared Special

ZSFab Cervical Interbody System

K232150 · Zsfab, Inc. · Orthopedic

Aug 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K232150 is an FDA 510(k) clearance for the ZSFab Cervical Interbody System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Zsfab, Inc. (Walthan, US). The FDA issued a Cleared decision on August 18, 2023, 30 days after receiving the submission on July 19, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232150 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2023
Decision Date	August 18, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — 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.