PMA P030022S038
- Device
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S038
- Product code
- MRA
- Decision date
- 2016-12-21
- 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 a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the R3 acetabular shells which are part of the Reflection Ceramic Acetabular Hip System.
Current openFDA PMA Record#
- Device
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S038
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-12-21
- Decision code
- APPR
- Date received
- 2016-07-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the R3 acetabular shells which are part of the Reflection Ceramic Acetabular Hip System.