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 Orthosis, Spinal Pedicle Fixation
510(k) Number K121615
Device Name 4CIS VANE SPINE SYSTEM
Applicant
Solco Biomedical Co., Ltd.
9700 Great Seneca Highway
Suite 302
Rockville,  MD  20850
Applicant Contact SAEYOUNG AHN
Correspondent
Solco Biomedical Co., Ltd.
9700 Great Seneca Highway
Suite 302
Rockville,  MD  20850
Correspondent Contact SAEYOUNG AHN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received06/01/2012
Decision Date 08/15/2012
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
-
-