Stabilis SA Cervical Stand-Alone System (Various PNs)— 510(k) K251735

Substantially Equivalent

Acuity Surgical Devices, LLC

FDA 510(k) clearance K251735 for Stabilis SA Cervical Stand-Alone System (Various PNs), Substantially Equivalent on 2025-07-30. Applicant: Acuity Surgical Devices, LLC.

Clearance details

Applicant: Acuity Surgical Devices, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-06-06
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.