FDA 510(k)

Corelink Foundation 3D Anterior Lumbar System

K-Number: K180556 · 2018-07-27

Decision Date2018-07-27

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Corelink Foundation 3D Anterior Lumbar System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2018-07-27 under approval number K180556. 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 Corelink Foundation 3D Anterior Lumbar System?

Corelink Foundation 3D Anterior Lumbar System is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Corelink, LLC. The 510(k) number is K180556.

When was Corelink Foundation 3D Anterior Lumbar System approved by the FDA?

Corelink Foundation 3D Anterior Lumbar System received FDA 510(k) clearance on 2018-07-27, under approval number K180556.

What company makes Corelink Foundation 3D Anterior Lumbar System?

Corelink Foundation 3D Anterior Lumbar System is manufactured by Corelink, LLC.

What is the FDA product code for Corelink Foundation 3D Anterior Lumbar System?

The FDA product code for Corelink Foundation 3D Anterior Lumbar System is MAX.

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Related PubMed Literature

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Other Devices by Corelink, LLC

K152237The Entasis Dual-Lead Sacroiliac Implant K163104Terrace Anterior Cervical Plate System K162496Foundation 3D Interbody K183239CoreLink F3D Lateral System K180814CoreLink® M3 Stand-Alone Anterior Lumbar System K182731Corelink Navigation Instruments

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Related Devices (Code: MAX)

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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.