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 appliance, fixation, spinal intervertebral body
510(k) Number K200846
Device Name Balteum™ Lumbar Plate System
Applicant
Huvexel Co., Ltd
101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro
Jungwon-gu
Seongnam-si,  KR 13207
Applicant Contact Sung Kyu Hur
Correspondent
Dio Medical Corporation
2900 Potshop Lane, Suite 200
Eagleville,  PA  19403
Correspondent Contact Milan George
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/31/2020
Decision Date 05/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-