Product code PAO

Device name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

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

Eligible

Definition

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

Source

FDA openFDA device classification dataset