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) | 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOSTEONICS CONSTRAINED ACETABULAR INSERT
ApplicantHOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677
PMA NumberP960047
Supplement NumberS002
Date Received03/24/2000
Decision Date05/01/2000
Reclassified Date 04/30/2002
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of the Trident Constrained Acetabular insert design, and the Modified PCA Co Cr, Modified V40 Co Cr, PCA CoCr+15 mm, PCA Zirconia and V40 Zirconia Femoral Heads to the Osteonics Constrained Acetabular Insert PMA.
-
-