FDA Registration
Active
🇺🇸 United States
PARAGON MEDICAL, INC.
Reg #: 1834331
·
FEI: 1000306340
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PARAGON MEDICAL, INC.
- Registration Number
- 1834331
- FEI Number
- 1000306340
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Matchett Dr.
- City
- PIERCETON
- State
- IN
- ZIP
- 46562
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082698
Owner / Operator
- Firm Name
- Paragon Medical
- Operator Number
- 9011072
- Address
- 8 Matchett Dr., --
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Stephane Langlois
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-01-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-17 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-17 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)