Keos Anterior Cervical Interbody Fusion Device System— 510(k) K212450

Substantially Equivalent

Keos

FDA 510(k) clearance K212450 for Keos Anterior Cervical Interbody Fusion Device System, Substantially Equivalent on 2022-06-06. Applicant: Keos.

Clearance details

Applicant: Keos
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2021-08-05
Decision date: 2022-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.