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FDA 510(k)

F3D Corpectomy System

K-Number: K202637 · 2020-12-23

ApplicantCorelink, LLC
Decision Date2020-12-23
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F3D Corpectomy 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 2020-12-23 under 510(k) number K202637. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3D Corpectomy System?

F3D Corpectomy System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Corelink, LLC. The 510(k) number is K202637.

When did F3D Corpectomy System receive FDA 510(k) clearance?

F3D Corpectomy System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K202637.

Who is the listed applicant for F3D Corpectomy 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 Corpectomy System?

The FDA product code for F3D Corpectomy System is MQP.

Other records listing Corelink, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

Official Source

View on FDA Database →

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

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