PMA P010014S100

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S100
Product code: NRA
Decision date: 2020-12-07
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Modification to the labeling to reflect the findings of the Post-Approval Study (PAS) Report, for the Oxford Partial Knee System.

Current openFDA PMA Record#

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S100
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2020-12-07
Decision code: APPR
Date received: 2020-10-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Modification to the labeling to reflect the findings of the Post-Approval Study (PAS) Report, for the Oxford Partial Knee System.