FDA Registration
Active
🇺🇸 United States
T-FIX® 3DSI Joint Fusion System
Reg #: 3014273501
·
FEI: 3014273501
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tangible Solutions, Inc. DBA Marle Tangible, Inc.
- Registration Number
- 3014273501
- FEI Number
- 3014273501
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 678 Yellow Springs Fairfield Rd
- City
- Fairborn
- State
- OH
- ZIP
- 45324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214123
Owner / Operator
- Firm Name
- Tangible Solutions, Inc. dba Marle Tangible, Inc.
- Operator Number
- 10056940
- Address
- 678 Yellow Springs Fairfield Rd
- City
- Fairborn
- State
- OH
- Postal Code
- 45324
- Country
- US
- Correspondent
- Kriss Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-06-27 |
Proprietary Names
T-FIX® 3DSI Joint Fusion System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)