Omnia Medical TiBrid-SA

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Omnia Medical, LLC

The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Tibrid-sa.

Pre-market Notification Details

Device IDK203207
510k NumberK203207
Device Name:Omnia Medical TiBrid-SA
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Omnia Medical, LLC 6 Canyon Rd, Suite 300 Morgantown,  WV  26508
ContactTroy Schifano
CorrespondentJordan Floyd
JALEX Medical 27865 Clemens Rd, Suite 3 Westlake,  OH  44145
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-30
Decision Date2020-12-23

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