PMA P030022S025
- Device
- REFLECTION CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S025
- Product code
- MRA
- Decision date
- 2013-08-30
- 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 1) ADDITIONAL SIZES OF R3 CERAMIC LINERS; AND 2) REVISION OF THE REFLECTION CERAMIC HIP SYSTEM LABELING (SURGICAL TECHNIQUE MANUAL AND SURGEON LABELING) TO REFLECT THE ADDITIONAL COMPONENTS.
Current openFDA PMA Record#
- Device
- REFLECTION CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S025
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2013-08-30
- Decision code
- APPR
- Date received
- 2013-06-06
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR 1) ADDITIONAL SIZES OF R3 CERAMIC LINERS; AND 2) REVISION OF THE REFLECTION CERAMIC HIP SYSTEM LABELING (SURGICAL TECHNIQUE MANUAL AND SURGEON LABELING) TO REFLECT THE ADDITIONAL COMPONENTS.