FDA Registration
Active
🇺🇸 United States
CARLSMED, INC.
Reg #: 3017936978
·
FEI: 3017936978
·
Expires 2026
Products
11
Proprietary Names
22
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- CARLSMED, INC.
- Registration Number
- 3017936978
- FEI Number
- 3017936978
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1800 Aston Avenue, Suite 100
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222009
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 | 2022-12-06 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-07-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-07-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-07-21 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-12-06 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-01-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-12-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2026-01-12 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-02-28 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-06-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-06 |
Proprietary Names
aprevo® anterior lumbar interbody fusion device with interfixation
aprevo® Inserter
aprevo® Cervical Interbody System
aprevo® posterior/transforaminal lumbar interbody fusion device
aprevo® anterior and lateral lumbar interbody fusion devices
aprevo® Awls
corra drill guide
corra cervical plating system
aprevo® transforaminal lumbar interbody fusion device
aprevo® anterior lumbar interbody fusion device
aprevo® lateral lumbar interbody fusion device
corra drills
aprevo® Digital Workflow
aprevo® Digital Segmentation
aprevo® TLIF-C Articulating System
aprevo anterior lumbar fusion device with interfixation
aprevo® Digital Planning
aprevo® handles
aprevo® inserter
aprevo® distractors
aprevo® drivers
aprevo® cervical interbody system
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198