Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vertiwedge® Intraosseous System

K-Number: K261810 · 2026-07-31

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

Device Summary

Vertiwedge® Intraosseous System 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 K261810. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vertiwedge® Intraosseous System?

Vertiwedge® Intraosseous System 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 K261810.

When did Vertiwedge® Intraosseous System receive FDA 510(k) clearance?

Vertiwedge® Intraosseous System received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261810.

Who is the listed applicant for Vertiwedge® Intraosseous System?

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 Vertiwedge® Intraosseous System?

The FDA product code for Vertiwedge® Intraosseous System is MQP.

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.

K261809Interwedge® Standalone LateralK260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsK241468Vertiwedge® Intraosseous SystemK241487Interwedge® Standalone Lateral

Related Devices (Code: MQP)

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.

K261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura MedicalK231134VerteLoc Spinal SystemSignature Orthopaedics Pty, Ltd.

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.

↑