Oryx Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Oryx Cervical Plate System.

Pre-market Notification Details

Device IDK192049
501k NumberK192049
Device Name:Oryx Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Innovasis, Inc. 614 East 3900 South Salt Lake City,  UT  84107
ContactMarshall Mccarty
CorrespondentMarshall Mccarty
Innovasis, Inc. 614 East 3900 South Salt Lake City,  UT  84107
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-31
Decision Date2019-11-08

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