FDA 510(k)

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System

K-Number: K231743 · 2023-12-08

Decision Date2023-12-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K231743. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System?

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Corelink, LLC. The 510(k) number is K231743.

When did F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System receive FDA 510(k) clearance?

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K231743.

Who is the listed applicant for F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System?

The FDA 510(k) record lists Corelink, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System?

The FDA product code for F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System is MAX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.