Product code OOG

Device name

Knee Arthroplasty Implantation System

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3560

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Source

FDA openFDA device classification dataset