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FDA 510(k)

Interwedge® Standalone Lateral

K-Number: K261809 · 2026-07-31

ApplicantFoundation Surgical Group
Decision Date2026-07-31
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Interwedge® Standalone Lateral is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Surgical Group. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K261809. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Interwedge® Standalone Lateral?

Interwedge® Standalone Lateral is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Foundation Surgical Group. The 510(k) number is K261809.

When did Interwedge® Standalone Lateral receive FDA 510(k) clearance?

Interwedge® Standalone Lateral received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261809.

Who is the listed applicant for Interwedge® Standalone Lateral?

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

What is the FDA product code for Interwedge® Standalone Lateral?

The FDA product code for Interwedge® Standalone Lateral is OVD.

Other records listing Foundation Surgical Group 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 SystemK260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsK241468Vertiwedge® Intraosseous SystemK241487Interwedge® Standalone Lateral

Related Devices (Code: OVD)

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.

K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical

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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