Vertiwedge® Intraosseous System— 510(k) K261810

Name: FDA 510(k) clearance K261810
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Foundation Surgical Group

FDA 510(k) clearance K261810 for Vertiwedge® Intraosseous System, Substantially Equivalent on 2026-07-31. Applicant: Foundation Surgical Group. Device class: 2.

Clearance details

Applicant: Foundation Surgical Group
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2026-06-01
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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K261031 — POSEIDON ST2026-07-10
K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04
K233359 — DOMINION Expandable Corpectomy System2024-03-08

More clearances from Foundation Surgical Group

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K261809 — Interwedge® Standalone Lateral2026-07-31

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.