Adaptable Ortho Innovations Intramedullary Nail System

Rod, Fixation, Intramedullary And Accessories

Adaptable Ortho Innovations, LLC

The following data is part of a premarket notification filed by Adaptable Ortho Innovations, Llc with the FDA for Adaptable Ortho Innovations Intramedullary Nail System.

Pre-market Notification Details

Device IDK210285
510k NumberK210285
Device Name:Adaptable Ortho Innovations Intramedullary Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Adaptable Ortho Innovations, LLC 65 Main Street Potsdam,  NY  13676
ContactSteve Palin
CorrespondentKyle Kovach
Jalex Medical 27865 Clemens Road, Suite #3 Westlake,  OH  44145
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-02
Decision Date2021-03-18

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.