InFrame™ Cannulated Fixation System

Screw, Fixation, Bone

ExsoMed, Corp.

The following data is part of a premarket notification filed by Exsomed, Corp. with the FDA for Inframe™ Cannulated Fixation System.

Pre-market Notification Details

Device IDK201430
510k NumberK201430
Device Name:InFrame™ Cannulated Fixation System
ClassificationScrew, Fixation, Bone
Applicant ExsoMed, Corp. 135 Columbia Aliso Viejo,  CA  92656
ContactJung Chang
CorrespondentPatricia Kontoudis
Regulatory And Quality Solutions, LLC 2790 Mosside Blvd, Suite 800 Monroeville,  PA  15146
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-06-20

© 2020
This site is not affiliated with or endorsed by the FDA.