QPQ

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Product code

QPQ

Device name

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Device class

Class 2

21 CFR

21 CFR 888.3630

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

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

FDA classification definition

A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.

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