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QADClass II

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

21 CFR 888.3023 / Orthopedic

QAD is the FDA product code for Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated, a class II device type, regulated under 21 CFR 888.3023. FDA's definition for this code reads: "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...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAD
Device name
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
FDA 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.
Regulation
21 CFR 888.3023
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code QAD

By decision year
7 clearances under product code QAD with a decision year between 2017 and 2024, 2020 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QAD by decision year
YearClearances
20171
20182
20203
20241

Applicants with the most clearances

Product code QAD
Applicants holding the most 510(k) clearances under product code QAD
ApplicantClearances
Illuminoss Medical Inc.6
Illminoss Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code