FDA Registration
Active
🇺🇸 United States
XENCO MEDICAL LLC
Reg #: 3011181154
·
FEI: 3011181154
·
Expires 2026
Products
14
Proprietary Names
18
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- XENCO MEDICAL LLC
- Registration Number
- 3011181154
- FEI Number
- 3011181154
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9930 Mesa Rim Road
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140786
Owner / Operator
- Firm Name
- Xenco Medical, LLC
- Operator Number
- 10047563
- Address
- 9930 Mesa Rim Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Jason Haider
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-10-06 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2023-09-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-11-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-11-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-11-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-11-30 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-11-30 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-11-30 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-04-11 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2017-01-17 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2020-10-19 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2018-11-06 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2021-02-17 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2020-10-19 |
Proprietary Names
Xenco Medical Cervical Interbody System
Argus Cervical Interbody System
SETx Cervical Interbody System
TrabeculeX Recovery App
SetX Pedicle Screw System
SetX Cervical Interbody System
SETx Pedicle Screw System
SETx Lumbar Interbody System
Xenco Medical Cervical Plate System
SETx Cervical Plate System
Saratoga Cervical Brace
TrabeculeX Bioactive Matrix
Tube Guard
Xenco Medical Lumbar Interbody System
Multilevel CerviKit
Cancellex Porous Titanium Lumbar Interbody
Tahiti Lumbar Brace
Sorrento Bone Graft Substitute
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device