FDA 510(k)

Foundation 3D Interbody

K-Number: K162496 · 2017-05-04

Decision Date2017-05-04

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Foundation 3D Interbody is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2017-05-04 under approval number K162496. 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 Foundation 3D Interbody?

Foundation 3D Interbody is a medical device that received FDA 510(k) clearance on 2017-05-04. It is manufactured by Corelink, LLC. The 510(k) number is K162496.

When was Foundation 3D Interbody approved by the FDA?

Foundation 3D Interbody received FDA 510(k) clearance on 2017-05-04, under approval number K162496.

What company makes Foundation 3D Interbody?

Foundation 3D Interbody is manufactured by Corelink, LLC.

What is the FDA product code for Foundation 3D Interbody?

The FDA product code for Foundation 3D Interbody is ODP.

Other Devices by Corelink, LLC

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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

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