ZSFab Cervical Interbody System

Intervertebral Fusion Device With Bone Graft, Cervical

ZSFab Inc.

The following data is part of a premarket notification filed by Zsfab Inc. with the FDA for Zsfab Cervical Interbody System.

Pre-market Notification Details

Device IDK202488
510k NumberK202488
Device Name:ZSFab Cervical Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant ZSFab Inc. 705 Cambridge Street STE 1 Cambridge,  MA  02141
ContactKai Xu
CorrespondentKaren E. Warden
BackRoads Consulting Inc. 12520 Heath Road Chesterland,  OH  44026
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-01-07

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