F3D Cervical Stand-Alone Interbody Fusion System— 510(k) K200087

Name: FDA 510(k) clearance K200087
Creator: U.S. Food and Drug Administration
Published: 2020-06-15

Substantially Equivalent

Corelink, LLC

FDA 510(k) clearance K200087 for F3D Cervical Stand-Alone Interbody Fusion System, Substantially Equivalent on 2020-06-15. Applicant: Corelink, LLC. Device class: 2.

Clearance details

Applicant: Corelink, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-01-15
Decision date: 2020-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Corelink, LLC

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K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System2023-12-08
K231494 — CoreLink Robotic Navigation Instruments2023-10-27
K232116 — CoreLink Navigation Instruments2023-08-16
K230329 — F3D Interbody System2023-06-06
K230880 — CoreLink Navigation Instruments2023-05-02

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.