PMA P010014S017

Device: OXFORD MENISCAL UNICOMPARTMENTAL KNEE
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S017
Product code: NRA
Decision date: 2008-02-20
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY.

Current openFDA PMA Record#

Device: OXFORD MENISCAL UNICOMPARTMENTAL KNEE
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S017
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2008-02-20
Decision code: APPR
Date received: 2007-08-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY.