FDA Registration
Active
🇺🇸 United States
SureMAX-SA
Reg #: 3013961579
·
FEI: 3013961579
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ADDITIVE IMPLANTS
- Registration Number
- 3013961579
- FEI Number
- 3013961579
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3101 E Shea Blvd Ste 122
- City
- Phoenix
- State
- AZ
- ZIP
- 85028
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211111
Owner / Operator
- Firm Name
- Additive Implants, Inc.
- Operator Number
- 10052268
- Address
- 3101 East Shea Boulevard, Suite 122
- City
- Phoenix
- State
- AZ
- Postal Code
- 85028
- Country
- US
- Correspondent
- John Ehteshami
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-09-24 |
Proprietary Names
SureMAX-SA
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility