F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System— 510(k) K231743

Name: FDA 510(k) clearance K231743
Creator: U.S. Food and Drug Administration
Published: 2023-12-08

Substantially Equivalent

Corelink, LLC

FDA 510(k) clearance K231743 for F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System, Substantially Equivalent on 2023-12-08. Applicant: Corelink, LLC. Device class: 2.

Clearance details

Applicant: Corelink, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-06-14
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K261020 — Symmetrix L Spinal System2026-07-14
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K231494 — CoreLink Robotic Navigation Instruments2023-10-27
K232116 — CoreLink Navigation Instruments2023-08-16
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K230880 — CoreLink Navigation Instruments2023-05-02
K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System2023-03-21

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.