Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K231715
Device Name MONDRIAN™ Anterior Lumbar Plate System
Applicant
Ctl Medical Corporation
4550 Excel Pkwy.
Suite 300
Addison,  TX  75001
Applicant Contact Sean Suh
Correspondent
Omnee Strategic Solutions, Inc.
7 Desrosiers Landing
South Grafton,  MA  01560
Correspondent Contact Dhaval Saraiya
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/13/2023
Decision Date 01/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-