FDA.reportPublic FDA data

PMA P010014S097

Device
The Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S097
Product code
NRA
Decision date
2020-04-27
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval to revise the Ultra-High Molecular Weight Polyethylene (UHMWPE) Direct Compression Molding (DCM) manufacturing process for the Oxford Partial Knee System meniscal bearings.

Current openFDA PMA Record#

Device
The Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S097
Product code
NRA
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-04-27
Decision code
APPR
Date received
2019-12-03
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to revise the Ultra-High Molecular Weight Polyethylene (UHMWPE) Direct Compression Molding (DCM) manufacturing process for the Oxford Partial Knee System meniscal bearings.