|
Device | OSTEONICS ABC/TRIDENT SYSTEMS |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
PMA Number | P000013 |
Supplement Number | S001 |
Date Received | 02/04/2003 |
Decision Date | 03/17/2003 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING ITEMS: 1) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40 ALUMINA HEADS AND ADDITIONAL C-TAPER ALUMINA HEAD SIZES (AND ASSOCIATED STEMS) 2) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40/C-TAPER AND MORSE TAPER ADAPTER SLEEVES (AND ASSOCIATED FEMORAL STEMS) 3) USE OF ADDITIONAL STYLES OF TRIDENT ACETABULAR SHELLS; AND 4) ASSOCIATED LABELING CHANGES DUE TO MODIFICATIONS IDENTIFIED ABOVE. |
Post-Approval Study | Show Report Schedule and Study Progress |