PMA P000013S001
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2003-03-17
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- 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.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2003-03-17
- Decision code
- APPR
- Date received
- 2003-02-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.