Data / Medical devices / United States / Promethean Restorative Inc.
Promethean Restorative Inc.: FDA-registered device maker in Castle Rock, CO, United States, 3 510(k) clearances
Promethean Restorative Inc. is registered with the FDA (registration 3030400539) in Castle Rock, CO, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030400539
- Address
- 333 Perry St Ste 210, Castle Rock, CO, United States, 80104
- Owner or operator
- Promethean Restorative Inc. (10090289)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- March 8, 2024
- Registered through
- 2026
- Brand names listed
- AUXOFUZE SI Delivery System, DYNAMIS Implant System, DYNAMIS Navigation System, DYNAMIS SI Screw System, FUSIO SI Allograft System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 12, 2026 | K252962 | DYNAMIS Navigation System | OLO | Substantially Equivalent | Promethean Restorative, LLC | accessdata.fda.gov |
| April 25, 2025 | K251075 | DYNAMIS Implant System | OUR | Substantially Equivalent | Promethean Restorative, LLC | accessdata.fda.gov |
| February 28, 2025 | K243565 | DYNAMIS SI Screw System | OUR | Substantially Equivalent | Promethean Restorative, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Sacroiliac Joint Fixation
- All makers of Screw, Fixation, Bone
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Orthopedic Manual Surgical Instrument
Updated January 12, 2026. 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.