Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

Product Code: QAD

Orthopedic General Optical Products / Medical

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 Polym

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 888.3023


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as QAD

4692Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activatedIn Vivo Cured Intramedullary Fixation Rod.

Total Product Life Cycle (TPLC) Devices

4692Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activatedIn Vivo Cured Intramedullary Fixation Rod.

Pre-market Notifications for QAD

K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminOss Medical, Inc.
K200295IlluminOss Bone Stabilization SystemIlluminOss Medical, Inc.
K183145IlluminOss Photodynamic Bone Stabilization SystemIlluminOss Medical, Inc.
K181228IlluminOss Bone Stabilization SystemIlluminOss Medical, Inc.

Global Unique Device Identification Database

USSL2213240Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL2213220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL2213160Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1700280Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1700260Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1700220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1700180Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1500280Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1500260Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1500220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1500180Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1100220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1100180Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL1100160Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
USSL0900220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Maude Adverse Events

ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2020-02-04
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2020-01-06
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2020-01-06
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2019-10-16
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2019-04-11
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2019-04-08
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2019-04-04
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2019-03-06
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC.2019-01-16
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2019-01-16
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2018-11-21
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2018-10-11
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEMILLUMINOSS MEDICAL INC2018-10-10
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.