FDA Registration
Active
🇺🇸 United States
DEMETRA, INC.
Reg #: 3040266825
·
FEI: 3040266825
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- DEMETRA, INC.
- Registration Number
- 3040266825
- FEI Number
- 3040266825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6800 Poplar Ave Ste 120
- City
- Germantown
- State
- TN
- ZIP
- 38138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200458
Owner / Operator
- Firm Name
- Demetra, Inc.
- Operator Number
- 10093966
- Address
- 6800 Poplar Ave, Ste 120
- City
- Germantown
- State
- TN
- Postal Code
- 38138
- Country
- US
- Correspondent
- Katie Taylor
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-08-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-08-25 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2025-08-25 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-08-25 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-08-25 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-08-25 |
Proprietary Names
TAILORED-C
DEMETRA SPINE INSTRUMENTS
TAILORED-H
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility