Align— 510(k) K222561

Substantially Equivalent

Acuity Surgical Devices, LLC

FDA 510(k) clearance K222561 for Align, Substantially Equivalent on 2022-09-23. Applicant: Acuity Surgical Devices, LLC.

Clearance details

Applicant: Acuity Surgical Devices, LLC
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2022-08-24
Decision date: 2022-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.