FDA Registration
Active
🇺🇸 United States
Response 5.5/6 Spine System
Reg #: 3009973699
·
FEI: 3009973699
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- B & J Medical LLC
- Registration Number
- 3009973699
- FEI Number
- 3009973699
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4268 East US Hwy 6
- City
- Kendallville
- State
- IN
- ZIP
- 46755
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150600
Owner / Operator
- Firm Name
- B&J Medical
- Operator Number
- 10042587
- Address
- 4268 East U.S. Hwy 6
- City
- Kendallville
- State
- IN
- Postal Code
- 46755
- Country
- US
- Correspondent
- Michael Winkelman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-10-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-10-26 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-10-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-10-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-10-26 |
Proprietary Names
Response 5.5/6 Spine System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)