UCerv Flux-C 3D Porous Titanium Cervical Interbody

Intervertebral Fusion Device With Bone Graft, Cervical

Ulrich Medical USA

The following data is part of a premarket notification filed by Ulrich Medical Usa with the FDA for Ucerv Flux-c 3d Porous Titanium Cervical Interbody.

Pre-market Notification Details

Device IDK220696
510k NumberK220696
Device Name:UCerv Flux-C 3D Porous Titanium Cervical Interbody
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Ulrich Medical USA 18221 Edison Avenue Chesterfield,  MO  63005
ContactHans Stover
CorrespondentHans Stover
Ulrich Medical USA 18221 Edison Avenue Chesterfield,  MO  63005
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-09
Decision Date2022-08-19

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