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 Thoracolumbosacral Pedicle Screw System
510(k) Number K120140
Device Name FOCUS SPINAL 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 HEE KYEONG JOO
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 HEE KYEONG JOO
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/18/2012
Decision Date 02/15/2012
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
-
-