PMA P010014S083

Device
Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S083
Product code
NRA
Decision date
2018-12-05
Classification
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Transfer in the morphology evaluation testing .

Current openFDA PMA Record#

Device
Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S083
Product code
NRA
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date
2018-12-05
Decision code
OK30
Date received
2018-11-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer in the morphology evaluation testing .