QHE

Shoulder Arthroplasty Implantation System

Product code

QHE

Device name

Shoulder Arthroplasty Implantation System

Device class

Class 2

21 CFR

21 CFR 888.3660

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

14

Summaries archived here

13 (direct download)

510(k) clearances (all years, FDA)

26 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (14)

Last three years. Most recent: 2026-06-09.

13 summaries are archived here for direct download.