FDA Registration
Active
🇺🇸 United States
DEGEN MEDICAL
Reg #: 3010663372
·
FEI: 3010663372
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- DEGEN MEDICAL
- Registration Number
- 3010663372
- FEI Number
- 3010663372
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1321C N Cashua Dr
- City
- Florence
- State
- SC
- ZIP
- 29501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201287
Owner / Operator
- Firm Name
- DeGen Medical
- Operator Number
- 10048016
- Address
- 1321-C North Cashua Drive
- City
- Florence
- State
- SC
- Postal Code
- 29501
- Country
- US
- Correspondent
- Craig Black
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-09-24 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2016-11-09 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-08-06 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2023-06-20 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-06-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-12-01 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-03-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-03-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-01-26 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2014-11-25 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-11-19 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-04-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-04-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-04-28 |
Proprietary Names
Impulse Interbody Fusion System
Augmenta
DeGen Navigated Instrumentation
Impulse AM Interbody Fusion System
Solar Lumbar Interbody Fusion System
Patient-Specific Implant (PSI) System
Connect-L
Hyper-C
Latitude-C
E3
JOUST
Cyclops
F1 MPS
Latitude-C AM Cervical Interbody Fusion System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility