ONX Large External Fixation System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

OrthoNovis, Inc.

The following data is part of a premarket notification filed by Orthonovis, Inc. with the FDA for Onx Large External Fixation System.

Pre-market Notification Details

Device IDK213905
510k NumberK213905
Device Name:ONX Large External Fixation System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant OrthoNovis, Inc. 1 Hargrove Grade, 2F Palm Coast,  FL  32137
ContactKen West
CorrespondentKen West
OrthoNovis, Inc. 1 Hargrove Grade, 2F Palm Coast,  FL  32137
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-14
Decision Date2022-08-25

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