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 ID: K201430
• 510k Number: K201430
• Device Name: InFrame™ Cannulated Fixation System
• Classification: Screw, Fixation, Bone
• Applicant: ExsoMed, Corp. 135 Columbia Aliso Viejo, CA 92656
• Contact: Jung Chang
• Correspondent: Patricia Kontoudis; Regulatory And Quality Solutions, LLC 2790 Mosside Blvd, Suite 800 Monroeville, PA 15146
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-01
• Decision Date: 2020-06-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B487EXINF9220100	K201430	000
B487EXINF9220280	K201430	000
B487EXINF9220260	K201430	000
B487EXINF9220240	K201430	000
B487EXINF9220220	K201430	000
B487EXINF9220200	K201430	000
B487EXINF9220180	K201430	000
B487EXINF9220160	K201430	000
B487EXINF9220140	K201430	000
B487EXINF9220300	K201430	000
B487EXINF9220320	K201430	000
B487EXINF9220340	K201430	000
B487EXINF9220500	K201430	000
B487EXINF9220480	K201430	000
B487EXINF9220460	K201430	000
B487EXINF9220440	K201430	000
B487EXINF9220420	K201430	000
B487EXINF9220400	K201430	000
B487EXINF9220380	K201430	000
B487EXINF9220360	K201430	000
B487EXINF9220120	K201430	000