FDA 510(k)

Foundation Surgical Navigated Lateral Disc Prep Instruments

K-Number: K260011 · 2026-04-16

ApplicantFoundation Surgical Group, Inc.

Decision Date2026-04-16

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Foundation Surgical Navigated Lateral Disc Prep Instruments is a medical device manufactured by Foundation Surgical Group, Inc.. It received FDA 510(k) clearance on 2026-04-16 under approval number K260011. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foundation Surgical Navigated Lateral Disc Prep Instruments?

Foundation Surgical Navigated Lateral Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Foundation Surgical Group, Inc.. The 510(k) number is K260011.

When was Foundation Surgical Navigated Lateral Disc Prep Instruments approved by the FDA?

Foundation Surgical Navigated Lateral Disc Prep Instruments received FDA 510(k) clearance on 2026-04-16, under approval number K260011.

What company makes Foundation Surgical Navigated Lateral Disc Prep Instruments?

Foundation Surgical Navigated Lateral Disc Prep Instruments is manufactured by Foundation Surgical Group, Inc..

What is the FDA product code for Foundation Surgical Navigated Lateral Disc Prep Instruments?

The FDA product code for Foundation Surgical Navigated Lateral Disc Prep Instruments is OLO.

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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.