Vertiwedge® Intraosseous System— 510(k) K261810
Substantially EquivalentFoundation Surgical Group
FDA 510(k) clearance K261810 for Vertiwedge® Intraosseous System, Substantially Equivalent on 2026-07-31. Applicant: Foundation Surgical Group. Device class: 2.
Summary
Foundation Surgical Group's Vertiwedge Intraosseous System is filed under MQP, spinal vertebral body replacement devices. The name says intraosseous; the record doesn't describe the system's parts.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
The applicant filed from Scottsdale, Arizona. The decision came 60 calendar days after FDA received it (June 1 to July 31, 2026).
Clearance details
- Applicant
- Foundation Surgical Group
- Product code
- Product code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scottsdale, AZ, US
Recent devices under product code MQP
view allMore clearances from Foundation Surgical Group
view allAdverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
Source: openFDA MAUDE database, through . 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.