PMA P010014S106

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S106
Product code: NRA
Decision date: 2024-08-19
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: an alternative detergent used in the polishing manufacturing process of the tibial tray and the femoral components of the Oxford Partial Knee System

Current openFDA PMA Record#

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S106
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2024-08-19
Decision code: OK30
Date received: 2024-06-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative detergent used in the polishing manufacturing process of the tibial tray and the femoral components of the Oxford Partial Knee System