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 intervertebral fusion device with bone graft, cervical
510(k) Number K120840
Device Name LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
Applicant
L&K BIOMED CO., LTD
#1104, ACE HIGH-END TOWER 3
CHA, 371-50 GASAN-DONG
GEUMCHEON-GU, SEOUL,  KR 153-803
Applicant Contact KI HYANG KIM
Correspondent
L&K BIOMED CO., LTD
#1104, ACE HIGH-END TOWER 3
CHA, 371-50 GASAN-DONG
GEUMCHEON-GU, SEOUL,  KR 153-803
Correspondent Contact KI HYANG KIM
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/20/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-