SImmetry+ System— 510(k) K250647

Substantially Equivalent

Sivantage

FDA 510(k) clearance K250647 for SImmetry+ System, Substantially Equivalent on 2025-07-29. Applicant: Sivantage.

Clearance details

Applicant: Sivantage
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2025-03-04
Decision date: 2025-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.