Interwedge® Standalone Lateral— 510(k) K241487

Name: FDA 510(k) clearance K241487
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Substantially Equivalent

Foundation Surgical Group, Inc.

FDA 510(k) clearance K241487 for Interwedge® Standalone Lateral, Substantially Equivalent on 2024-10-02. Applicant: Foundation Surgical Group, Inc.. Device class: 2.

Clearance details

Applicant: Foundation Surgical Group, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-05-24
Decision date: 2024-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
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More clearances from Foundation Surgical Group, Inc.

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K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments2026-04-16
K241468 — Vertiwedge® Intraosseous System2024-11-07

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.