• 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 screw, fixation, bone
510(k) Number K012000
Device Name 1.5MM BONE FIXATION KIT
Original Applicant
BIONX IMPLANTS, LTD.
p.o. box 3
herminkatu 6-8l
tampere,  FI sp-33721
Original Contact tuija annala
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received06/27/2001
Decision Date 07/18/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-