Shoulder Prosthesis, Reverse Configuration

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

Classification

FDA Product Code: PHX
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

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Market data

Cleared 510(k) submissions: 200
Registered establishments: 191

Source

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