DYNAMIS Implant System— 510(k) K251075

Substantially Equivalent

Promethean Restorative, LLC

FDA 510(k) clearance K251075 for DYNAMIS Implant System, Substantially Equivalent on 2025-04-25. Applicant: Promethean Restorative, LLC.

Clearance details

Applicant: Promethean Restorative, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2025-04-08
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.