F3D-C2 Cervical Stand-Alone System— 510(k) K211417

Substantially Equivalent

Corelink, LLC

FDA 510(k) clearance K211417 for F3D-C2 Cervical Stand-Alone System, Substantially Equivalent on 2022-02-04. Applicant: Corelink, LLC.

Clearance details

Applicant: Corelink, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2021-05-07
Decision date: 2022-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.