Data / Medical devices / United States / SINTX Technologies Inc.
SINTX Technologies Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 1 510(k) clearance
SINTX Technologies Inc. is registered with the FDA (registration 3005032068) in Salt Lake City, UT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 17, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005032068
- Address
- 1885 W 2100 S, Salt Lake City, UT, United States, 84119
- Owner or operator
- SINTX Technologies (9071516)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 22, 2008
- Registered through
- 2027
- Brand names listed
- MC^2 and CSC, SiNAPTIC Osteotomy Wedge System, Valeo II Interbody Fusion Device System - Lumbar
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Wedge | PLF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| October 17, 2025 | K252254 | Osteotomy Wedge System | PLF | Substantially Equivalent | Sinaptic Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Bone Wedge
- All makers of Spinal Vertebral Body Replacement Device
Updated October 17, 2025. 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.