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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K231322
Device Name Fix2Lock(PEEK Self Punching)
Applicant
Osteonic Co., Ltd.
1206ho, 38, Digital-Ro, 29-Gil, Guro-Gu
Seoul,  KR 08381
Applicant Contact Da Kyung Ham
Correspondent
Wise Company, Inc.
#507, #508, 166 Gasandigital 2-Ro, Geumcheon-Gu
Seoul,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/08/2023
Decision Date 06/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-