Interwedge® Standalone Lateral— 510(k) K241487

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..

Clearance details

Applicant: Foundation Surgical Group, Inc.
Product code: Code OVD
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 ↗

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.