FDA Registration
Active
🇺🇸 United States
aprevo® anterior lumbar interbody fusion device with interfixation
Reg #: 3017936978
·
FEI: 3017936978
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CARLSMED, INC.
- Registration Number
- 3017936978
- FEI Number
- 3017936978
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1800 Aston Avenue, Suite 100
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241477
Owner / Operator
- Firm Name
- Carlsmed, Inc.
- Operator Number
- 10080208
- Address
- 1800 Aston Avenue, Suite 100
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Mike Cordonnier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-02-25 |
Proprietary Names
aprevo® anterior lumbar interbody fusion device with interfixation
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198