FDA Registration
Active
🇺🇸 United States
ISOLA
Reg #: 1526439
·
FEI: 1526439
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DEPUY SPINE, INC.
- Registration Number
- 1526439
- FEI Number
- 1526439
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 325 Paramount Drive
- City
- RAYNHAM
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013441
Owner / Operator
- Firm Name
- DePuy Spine, Inc.
- Operator Number
- 1526439
- Address
- 325 Paramount Drive
- City
- Raynham
- State
- MA
- Postal Code
- 02767
- Country
- US
- Correspondent
- Karen Parker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2007-11-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2007-11-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2007-11-13 |
Proprietary Names
ISOLA
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility