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 Plate, Fixation, Bone
510(k) Number K231213
Device Name HKT Anatomical Locking Trauma System
Applicant
Hankil Tech Medical Co., Ltd.
452-29, Pureundeulpan-Ro, Paltan-Myeon
Hwaseong-Si,  KR 18532
Applicant Contact Kim Jeong-Yup
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/28/2023
Decision Date 01/19/2024
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
-
-