Data / Medical devices / United States / Demetra, Inc.
Demetra, Inc.: FDA-registered device maker in Germantown, TN, United States, 2 510(k) clearances
Demetra, Inc. is registered with the FDA (registration 3040266825) in Germantown, TN, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3040266825
- Address
- 6800 Poplar Ave Ste 120, Germantown, TN, United States, 38138
- Owner or operator
- Demetra, Inc. (10093966)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 25, 2025
- Registered through
- 2026
- Brand names listed
- DEMETRA SPINE INSTRUMENTS, TAILORED-C, TAILORED-H
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 18, 2022 | K222903 | Tailored-H Cervical Stand Alone System | OVE | Substantially Equivalent | Bespoke Technologies, LLC | accessdata.fda.gov |
| December 28, 2020 | K200458 | Tailored-C Cervical Interbody Fusion System | ODP | Substantially Equivalent | Bespoke Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Awl
- All makers of Bit, Drill
- All makers of Tray, Surgical, Instrument
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
Updated November 18, 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.