PMA P000013S009
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S009
- Product code
- MRA
- Decision date
- 2009-05-07
- 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 CHANGES TO THE LABELING (I.E., SURGICAL PROTOCOL) OF THE TRIDENT HIP SYSTEM. THESE MODIFICATIONS INCLUDE CREATING SEPARATE AND DISTINCT SURGICAL PROTOCOLS, ONE FOR THE TRIDENT PSL SHELL AND ONE FOR THE TRIDENT HEMISPHERICAL SHELL, IN ORDER TO CLARIFY THE DIFFERENCES IN REAMING TECHNIQUES BETWEEN THE TWO SHELLS, AS WELL AS OTHER IMPROVEMENTS TO THE SURGICAL PROTOCOL.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC/TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S009
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2009-05-07
- Decision code
- APPR
- Date received
- 2009-04-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING (I.E., SURGICAL PROTOCOL) OF THE TRIDENT HIP SYSTEM. THESE MODIFICATIONS INCLUDE CREATING SEPARATE AND DISTINCT SURGICAL PROTOCOLS, ONE FOR THE TRIDENT PSL SHELL AND ONE FOR THE TRIDENT HEMISPHERICAL SHELL, IN ORDER TO CLARIFY THE DIFFERENCES IN REAMING TECHNIQUES BETWEEN THE TWO SHELLS, AS WELL AS OTHER IMPROVEMENTS TO THE SURGICAL PROTOCOL.