Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
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 yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 3 |
| 2024 | 1 |
Applicants with the most clearances
Product code QAD| Applicant | Clearances |
|---|---|
| Illuminoss Medical Inc. | 6 |
| Illminoss Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
