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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-01-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08500351650005 K202488 000
08500351650098 K202488 000
08500351650081 K202488 000
08500351650074 K202488 000
08500351650067 K202488 000
08500351650050 K202488 000
08500351650043 K202488 000
08500351650036 K202488 000
08500351650029 K202488 000
08500351650104 K202488 000
08500351650111 K202488 000
08500351650197 K202488 000
08500351650180 K202488 000
08500351650173 K202488 000
08500351650166 K202488 000
08500351650159 K202488 000
08500351650142 K202488 000
08500351650135 K202488 000
08500351650128 K202488 000
08500351650012 K202488 000

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