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FDA 510(k)

F3D Cervical Stand-Alone Interbody Fusion System

K-Number: K200087 · 2020-06-15

ApplicantCorelink, LLC
Decision Date2020-06-15
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F3D Cervical Stand-Alone Interbody Fusion System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2020-06-15 under approval number K200087. 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 Cervical Stand-Alone Interbody Fusion System?

F3D Cervical Stand-Alone Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-06-15. It is manufactured by Corelink, LLC. The 510(k) number is K200087.

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

F3D Cervical Stand-Alone Interbody Fusion System received FDA 510(k) clearance on 2020-06-15, under approval number K200087.

What company makes F3D Cervical Stand-Alone Interbody Fusion System?

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

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

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

Related Clinical Trials

NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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

View all 23 devices →

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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