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FDA 510(k)

F3D-C2 Cervical Stand-Alone System

K-Number: K211417 · 2022-02-04

ApplicantCorelink, LLC
Decision Date2022-02-04
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F3D-C2 Cervical Stand-Alone System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2022-02-04 under approval number K211417. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3D-C2 Cervical Stand-Alone System?

F3D-C2 Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Corelink, LLC. The 510(k) number is K211417.

When was F3D-C2 Cervical Stand-Alone System approved by the FDA?

F3D-C2 Cervical Stand-Alone System received FDA 510(k) clearance on 2022-02-04, under approval number K211417.

What company makes F3D-C2 Cervical Stand-Alone System?

F3D-C2 Cervical Stand-Alone System is manufactured by Corelink, LLC.

What is the FDA product code for F3D-C2 Cervical Stand-Alone System?

The FDA product code for F3D-C2 Cervical Stand-Alone System is OVE.

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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 K180556Corelink Foundation 3D Anterior Lumbar System

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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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