FDA Registration
Active
🇺🇸 United States
FOUNDATION SURGICAL GROUP
Reg #: 3039167712
·
FEI: 3039167712
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- FOUNDATION SURGICAL GROUP
- Registration Number
- 3039167712
- FEI Number
- 3039167712
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7327 E Tierra Buena Ln Ste 101
- City
- Scottsdale
- State
- AZ
- ZIP
- 85260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241487
Owner / Operator
- Firm Name
- Foundation Surgical Group
- Operator Number
- 10093677
- Address
- 7327 E Tierra Buena Lane, Suite 101
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85260
- Country
- US
- Correspondent
- Christopher Reah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-06-20 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-06-20 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-06-20 |
Proprietary Names
Interwedge
Vertiwedge
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility