FDA 510(k)

Interwedge® Standalone Lateral

K-Number: K241487 · 2024-10-02

ApplicantFoundation Surgical Group, Inc.

Decision Date2024-10-02

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Interwedge® Standalone Lateral is a medical device manufactured by Foundation Surgical Group, Inc.. It received FDA 510(k) clearance on 2024-10-02 under approval number K241487. 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 2024-10-02. It is manufactured by Foundation Surgical Group, Inc.. The 510(k) number is K241487.

When was Interwedge® Standalone Lateral approved by the FDA?

Interwedge® Standalone Lateral received FDA 510(k) clearance on 2024-10-02, under approval number K241487.

What company makes Interwedge® Standalone Lateral?

Interwedge® Standalone Lateral is manufactured by Foundation Surgical Group, Inc..

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

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

Other Devices by Foundation Surgical Group, Inc.

K241468Vertiwedge® Intraosseous System K260011Foundation Surgical Navigated Lateral Disc Prep Instruments

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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.