Data / Medical devices / United States / Foundation Surgical Group
Foundation Surgical Group: FDA-registered device maker in Scottsdale, AZ, United States, 3 510(k) clearances
Foundation Surgical Group is registered with the FDA (registration 3039167712) in Scottsdale, AZ, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3039167712
- Address
- 7327 E Tierra Buena Ln Ste 101, Scottsdale, AZ, United States, 85260
- Owner or operator
- Foundation Surgical Group (10093677)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 20, 2025
- Registered through
- 2027
- Brand names listed
- Foundation Surgical Group Navigated Lateral Disc Prep System, Interwedge, Vertiwedge
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2026 | K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | OLO | Substantially Equivalent | Foundation Surgical Group, Inc. | accessdata.fda.gov |
| November 7, 2024 | K241468 | Vertiwedge® Intraosseous System | MQP | Substantially Equivalent | Foundation Surgical Group, Inc. | accessdata.fda.gov |
| October 2, 2024 | K241487 | Interwedge® Standalone Lateral | OVD | Substantially Equivalent | Foundation Surgical Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Spinal Vertebral Body Replacement Device
- All makers of Orthopedic Stereotaxic Instrument
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.