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FDA 510(k)

F3D Interbody System

K-Number: K230329 · 2023-06-06

ApplicantCorelink, LLC
Decision Date2023-06-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F3D Interbody System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2023-06-06 under approval number K230329. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3D Interbody System?

F3D Interbody System is a medical device that received FDA 510(k) clearance on 2023-06-06. It is manufactured by Corelink, LLC. The 510(k) number is K230329.

When was F3D Interbody System approved by the FDA?

F3D Interbody System received FDA 510(k) clearance on 2023-06-06, under approval number K230329.

What company makes F3D Interbody System?

F3D Interbody System is manufactured by Corelink, LLC.

What is the FDA product code for F3D Interbody System?

The FDA product code for F3D Interbody System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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