Data / Medical devices / United States / Cortex Manufacturing, LLC
Cortex Manufacturing, LLC: FDA-registered device maker in Byhalia, MS, United States, 2 510(k) clearances
Cortex Manufacturing, LLC is registered with the FDA (registration 3008706707) in Byhalia, MS, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 12, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008706707
- Address
- 7753 Highway 72, Byhalia, MS, United States, 38611
- Owner or operator
- Cortex Manufacturing, LLC (10034161)
- Roles
- Manufacturer
- First device listed
- November 11, 2010
- Registered through
- 2026
- Brand names listed
- Clearsight Bolus, Fleximarc, Mixed-Media Markers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 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 |
|---|---|---|---|---|---|---|
| January 12, 2011 | K102506 | MIXED MEDIA MARKER | NEU | Substantially Equivalent | Cortex Manufacturing, Inc. | accessdata.fda.gov |
| February 24, 2010 | K100267 | FLEXIMARC, MODEL CM-0.9-2-10-GG-L | IYE | Substantially Equivalent | Cortex Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Phantom, Anthropomorphic, Radiographic
- All makers of Accelerator, Linear, Medical
- All makers of Marker, Radiographic, Implantable
Updated January 12, 2011. 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.