Product code PLW

Device name

Acetabular Cup Orientation System

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3350

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.

Source

FDA openFDA device classification dataset