QAD

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Product code

QAD

Device name

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Device class

Class 2

21 CFR

21 CFR 888.3023

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-19.

1 summaries are archived here for direct download.