• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K120419
Model NA0916-NA1224
Device Name DYNA LOCKING ANKLE NAIL
Original Applicant
U&I CORP.
20, sandan-ro 76beon-gil(rd)
uijeongbu-si,  KR 480-859
Original Contact gyeong-je kwon
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/21/2012
Decision Date 05/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-