Data / Medical devices / France / Noraker
Noraker: FDA-registered device maker in LYON Auvergne-Rhone-Alpes, France, 3 510(k) clearances
Noraker is registered with the FDA (registration 3033809758) in LYON Auvergne-Rhone-Alpes, France. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033809758
- Address
- 60 avenue Rockefeller, LYON Auvergne-Rhone-Alpes, France, 69008
- Owner or operator
- NORAKER (10090225)
- Roles
- Manufacturer
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- ARTHREX QUICKSET, ARTHREX QUICKSET CANNULA, ARTHREX QUICKSET DELIVERING GUN, ARTHREX QUICKSET KIT, AktiBone Granules, GRAFTYS CANNULA 7G, GRAFTYS QUICKSET, GRAFTYS QUICKSET DELIVERING GUN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Cement | KIH | 1 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K242782 | GlassBone Granules | MQV | Substantially Equivalent | Noraker | accessdata.fda.gov |
| July 12, 2023 | K231714 | Graftys Quickset | MQV | Substantially Equivalent | Graftys | accessdata.fda.gov |
| April 22, 2010 | K093343 | GRAFTY QUICKSET | MQV | Substantially Equivalent | Graftys | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Dispenser, Cement
Updated December 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.