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 Screw, Fixation, Intraosseous
510(k) Number K251569
Device Name Bone Screw
Applicant
Osstem Implant Co., Ltd.
66-16, Bansong-Ro 513beon-Gil, Haeundae-Gu,
Busan,  KR 48002
Applicant Contact Kang Seungju
Correspondent
Hiossen, Inc.
85 Ben Fariless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Mateusz Leszczak
Regulation Number872.4880
Classification Product Code
DZL  
Date Received05/22/2025
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-