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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTRIDENT CERAMIC ON CERAMIC ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP000013
Supplement NumberS006
Date Received02/22/2006
Decision Date03/14/2006
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process changes by ceramtec, inc. For the biolox forte ceramic femoral heads and inserts.
-
-