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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 the device name listed in this FDA 510(k) record. The listed applicant is Foundation Surgical Group, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) 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. The listed applicant is Foundation Surgical Group, Inc.. The 510(k) number is K260011.

When did Foundation Surgical Navigated Lateral Disc Prep Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for Foundation Surgical Navigated Lateral Disc Prep Instruments?

The FDA 510(k) record lists Foundation Surgical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Foundation Surgical Group, Inc. as applicant

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.

K261810Vertiwedge® Intraosseous SystemK261809Interwedge® Standalone LateralK241468Vertiwedge® Intraosseous SystemK241487Interwedge® Standalone Lateral

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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