PMA P150030S023

Device: R3TM Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S023
Product code: MRA
Decision date: 2022-08-08
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Change to replace the existing grinding and buffing wheels utilized in the polishing process with size-specific custom wheels for the R3 acetabular shells.

Current openFDA PMA Record#

Device: R3TM Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S023
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-08-08
Decision code: OK30
Date received: 2022-07-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to replace the existing grinding and buffing wheels utilized in the polishing process with size-specific custom wheels for the R3 acetabular shells.