PMA P030022S041
- Device
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S041
- Product code
- MRA
- Decision date
- 2016-12-08
- 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 addition of an inspection procedure to the Ceramic Femoral Heads used with the Reflection and R3 Ceramic Liners.
Current openFDA PMA Record#
- Device
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S041
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-12-08
- Decision code
- APPR
- Date received
- 2016-11-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of an inspection procedure to the Ceramic Femoral Heads used with the Reflection and R3 Ceramic Liners.