Omnia Medical Trauma Screws

Screw, Fixation, Bone

Omnia Medical, LLC

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

Pre-market Notification Details

Device IDK192096
510k NumberK192096
Device Name:Omnia Medical Trauma Screws
ClassificationScrew, Fixation, Bone
Applicant Omnia Medical, LLC 6 Canyon Rd Suite 300 Morgantown,  WV  26508
ContactTroy Schifano
CorrespondentDaniel Johnson
JALEX Medical 30311 Clemens Rd Suite 5D Westlake,  OH  44145
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2020-02-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843511100742 K192096 000
00843511100735 K192096 000

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