Shoulder Arthroplasty Implantation System

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

Classification

FDA Product Code: QHE
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: N
Third-party review: N

Definition

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Market data

Cleared 510(k) submissions: 24
Registered establishments: 34

Source

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