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 Sacroiliac Joint Fixation
510(k) Number K262522
Device Name Odys-SI Screw
Applicant
Medyssey Co, Ltd.
129 Hanbang Expo-Ro
Jecheon-Si,  KR 27116
Applicant Contact Yujin Go
Correspondent
Medyssey Co, Ltd.
129 Hanbang Expo-Ro
Jecheon-Si,  KR 27116
Correspondent Contact Yujin Go
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/22/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-