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FDA 510(k)

Foundation 3D Interbody

K-Number: K162496 · 2017-05-04

ApplicantCorelink, LLC
Decision Date2017-05-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Foundation 3D Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2017-05-04 under 510(k) 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. The listed applicant is Corelink, LLC. The 510(k) number is K162496.

When did Foundation 3D Interbody receive FDA 510(k) clearance?

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

Who is the listed applicant for Foundation 3D Interbody?

The FDA 510(k) record lists Corelink, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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