• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name screw, fixation, bone
510(k) Number K024060
Device Name MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 -1677
Original Contact karen ariemma
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/09/2002
Decision Date 12/20/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-