Products Classified as NRA

4739

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing

Total Product Life Cycle (TPLC) Devices

4739

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing

FDA Consensus Standards

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing [31877]	21 CFR Unclassified 🔎
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing [33949]	21 CFR Unclassified 🔎
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing [34716]	21 CFR Unclassified 🔎

Pre-market Approvals for NRA

P010014

Oxford Partial Knee System

BIOMET MANUFACTURING CORP.

Global Unique Device Identification Database

00880304512047	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304511804	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510227	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510210	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510203	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510197	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510180	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510173	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510166	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510159	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510142	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510135	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510128	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510111	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
00880304510104	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

Maude Adverse Events

OXF ANAT BRG LT MD SIZE 5 PMA	BIOMET UK LTD.	2020-03-30
OXF UNI CMNTLS TIB SZ D RM	BIOMET UK LTD.	2020-03-30
OXF ANAT BRG RT MD SIZE 4 PMA	BIOMET UK LTD.	2020-03-30
OXF TWIN-PEG CMNTD FEM MD PMA	BIOMET UK LTD.	2020-03-22
OXF UNI TIB TRAY SZA LM/RL PMA	BIOMET UK LTD.	2020-03-22
OXF ANAT BRG LT MD SIZE 5 PMA	BIOMET UK LTD.	2020-03-22
OXF ANAT BRG RT LG SIZE 4 PMA	BIOMET UK LTD.	2020-03-22
OXF UNI TIB TRAY SZ AA RM PMA	BIOMET UK LTD.	2020-03-22
OXFORD UNI TWIN-PEG FEMORAL XS	BIOMET UK LTD.	2020-03-22
OXFORD PKS ANATOMIC ARCOM MENISCAL BRG	BIOMET UK LTD.	2020-03-22
OXFORD UNI TWIN-PEG FEMORAL XS	BIOMET UK LTD.	2020-03-21
OXF ANAT BRG LT SM SIZE 3 PMA SML SZ 3	BIOMET UK LTD.	2020-03-17
OXF ANAT BRG LT X-SM SZ 5 PMA	BIOMET UK LTD.	2020-03-11
OXF UNI TIB TRAY SZ C RM PMA	BIOMET UK LTD.	2020-03-09
OXF TWIN-PEG CMNTD FEM MD PMA	BIOMET UK LTD.	2020-03-09
OXF ANAT BRG RT MD SIZE 4 PMA	BIOMET UK LTD.	2020-03-09
OXFORD UNI TWIN-PEG FEMORAL SM	BIOMET UK LTD.	2020-03-02
UNKNOWN OXFORD TIBIAL COMPONENT	BIOMET UK LTD.	2020-02-28
UNKNOWN OXFORD FEMORAL COMPONENT	BIOMET UK LTD.	2020-02-28
OXF UNI TIB TRAY SZ B LM PMA	BIOMET UK LTD.	2020-02-28
OXF ANAT BRG LT SM SIZE 4 PMA	BIOMET UK LTD.	2020-02-28
OXF TWIN-PEG CMNTD FEM SM PMA	BIOMET UK LTD.	2020-02-28
OXF ANAT BRG LT MD SIZE 3 PMA	BIOMET UK LTD.	2020-02-18
OXF ANAT BRG LT X-SM SZ 3 PMA	BIOMET UK LTD.	2020-02-12
UNKNOWN OXFORD FEMORAL COMPONENT	BIOMET UK LTD.	2020-02-12
UNKNOWN OXFORD TIBIAL COMPONENT	BIOMET UK LTD.	2020-02-12
OXFORD UNI TWIN-PEG FEMORAL SM	BIOMET UK LTD.	2020-02-03
OXF ANAT BRG LT SM SIZE 3 PMA	BIOMET UK LTD.	2020-01-26
OXF UNI TIB TRAY SZA LM/RL PMA	BIOMET UK LTD.	2020-01-26
OXF TWIN-PEG CMNTD FEM SM PMA	BIOMET UK LTD.	2020-01-26
OXF ANAT BRG LT SM SIZE 5 PMA	BIOMET UK LTD.	2020-01-26
OXF ANAT BRG RT SM SIZE 5 PMA	BIOMET UK LTD.	2020-01-24
OXFORD UNI FEMORAL SM	BIOMET UK LTD.	2020-01-24
OXF UNI TIB TRAY SZ C RM PMA	BIOMET UK LTD.	2020-01-24
OXF TWIN-PEG CMNTD FEM MD PMA	BIOMET UK LTD.	2020-01-22
OXF ANAT BRG LT MD SIZE 5 PMA	BIOMET UK LTD.	2020-01-22
OXF UNI TIB TRAY SZ D LM PMA	BIOMET UK LTD.	2020-01-22
OXF UNI TIB TRAY SZ D LM PMA	BIOMET UK LTD.	2020-01-22
OXF TWIN-PEG CMNTD FEM MD PMA	.	2020-01-22
OXF ANAT BRG LT MD SIZE 4 PMA	BIOMET UK LTD.	2020-01-22
OXF ANAT BRG RT MD SIZE 3 PMA	BIOMET UK LTD.	2020-01-15
UNKNOWN OXFORD TIBIAL COMPONENT	BIOMET UK LTD.	2020-01-14
UNKNOWN OXFORD BEARING	BIOMET UK LTD.	2020-01-14
UNKNOWN OXFORD FEMORAL COMPONENT	BIOMET UK LTD.	2020-01-14
UNKNOWN OXFORD FEMORAL COMPONENT	BIOMET UK LTD.	2020-01-13
UNKNOWN OXFORD BEARING	BIOMET UK LTD.	2020-01-13
UNKNOWN OXFORD TIBIAL COMPONENT	BIOMET UK LTD.	2020-01-13
OXFORD UNI TWIN-PEG FEMORAL SM	BIOMET UK LTD.	2020-01-10
OXF ANAT BRG LT MD SIZE 4 PMA	.	2020-01-09
OXF TWIN-PEG CMNTD FEM MD PMA	BIOMET UK LTD.	2020-01-09

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