DeviceClearance

Product code QHQ— Orthopedic

Arthrex Eclipse Shoulder Prosthesis System

Classification name
Total Shoulder Arthroplasty System
Device class
Class 2
Regulation
21 CFR 888.3660
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“To treat pain and lack of function in the shoulder.”

— U.S. Food and Drug Administration, device classification record for product code QHQ under 21 CFR 888.3660, via openFDA

Market context for product code QHQ

FDA has cleared 1 device under product code QHQ, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QHQ

Recent clearances under product code QHQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.