UNITY Sacroiliac Joint Fixation System— 510(k) K222448

Substantially Equivalent

Dio Medical Corporation

FDA 510(k) clearance K222448 for UNITY Sacroiliac Joint Fixation System, Substantially Equivalent on 2022-10-13. Applicant: Dio Medical Corporation.

Clearance details

Applicant: Dio Medical Corporation
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2022-08-15
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Norriton, PA, 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.