Data / Medical devices / United States / Demetra, Inc.
Demetra, Inc.: FDA-registered device maker in Hudson, MA, United States, 1 510(k) clearance
Demetra, Inc. is registered with the FDA (registration 3024124172) in Hudson, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024124172
- Address
- 43 Broad St Ste B403, Hudson, MA, United States, 01749
- Owner or operator
- Demetra, Inc (10085945)
- Roles
- Manufacturer
- First device listed
- September 14, 2022
- Registered through
- 2026
- Brand names listed
- AlloGr8 Posterior Allograft System, OrthoFundamentals Trellis SI Joint Fusion System And Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | 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 |
|---|---|---|---|---|---|---|
| April 11, 2022 | K212962 | TRELLIS SI Joint Fusion System | OUR | Substantially Equivalent | Orthofundamentals, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2022. 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.