Cleared Traditional

ZSFab Cervical Interbody System

K202488 · Zsfab, Inc. · Orthopedic

Jan 2021

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K202488 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. (Cambridge, US). The FDA issued a Cleared decision on January 7, 2021, 129 days after receiving the submission on August 31, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K202488 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2020
Decision Date	January 07, 2021
Days to Decision	129 days
Submission Type	Traditional
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.