FDA Registration
Active
🇺🇸 United States
SINTX Technologies Inc.
Reg #: 3005032068
·
FEI: 3005032068
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- SINTX Technologies Inc.
- Registration Number
- 3005032068
- FEI Number
- 3005032068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1885 W 2100 S
- City
- Salt Lake City
- State
- UT
- ZIP
- 84119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252254
Owner / Operator
- Firm Name
- SINTX Technologies
- Operator Number
- 9071516
- Address
- 1885 W 2100 S
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84119
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2026-01-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-01-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-01-02 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-22 |
Proprietary Names
SiNAPTIC Osteotomy Wedge System
Valeo II Interbody Fusion Device System - Lumbar
MC^2 and CSC
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)