PMA P010014S074

Device

Oxford Partial Knee System

Applicant

Biomet Manufacturing Corp

PMA number

P010014

Supplement

S074

Product code

NRA

Decision date

2018-04-11

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

Approval for updates to compression molding work instructions including replacement of cotton socks with polyethylene bags, reduction in mold agent, and addition of mold presses.

Summary

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