Product code QHQ

Device name

Total Shoulder Arthroplasty System

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3660

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To treat pain and lack of function in the shoulder.

Source

FDA openFDA device classification dataset