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 Orthopedic Stereotaxic Instrument
510(k) Number K252037
Device Name CUVIS-joint (CJ150)
Applicant
Curexo, Inc.
3rd 4th Floor 480, Wiryesunhwan-Ro, Songpa-Gu
Seoul,  KR 05814
Applicant Contact Jay Koh
Correspondent
Curexo, Inc.
3rd 4th Floor 480, Wiryesunhwan-Ro, Songpa-Gu
Seoul,  KR 05814
Correspondent Contact Jay Koh
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/30/2025
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-