PMA P030022S047
- Device
- Reflection Ceramic Hip System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S047
- Product code
- MRA
- Decision date
- 2022-06-21
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Removing the benchtop grinding wheel and using a manual process to deburr the R3 Acetabular Shells.
Current openFDA PMA Record#
- Device
- Reflection Ceramic Hip System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S047
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2022-06-21
- Decision code
- OK30
- Date received
- 2022-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removing the benchtop grinding wheel and using a manual process to deburr the R3 Acetabular Shells.