PMA P010014S103

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S103
Product code: NRA
Decision date: 2022-10-25
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Introduction of a FOBA laser for the etching process of the Oxford Partial Knee System at Biomet Orthopedics, Warsaw, IN.

Current openFDA PMA Record#

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S103
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-25
Decision code: OK30
Date received: 2022-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of a FOBA laser for the etching process of the Oxford Partial Knee System at Biomet Orthopedics, Warsaw, IN.