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

PAO · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3660

Classification

FDA Product Code: PAO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3660
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 70

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown