FDA Registration
Active
🇺🇸 United States
SURGICAL INSTRUMENT MANUFACTURERS, LLC
Reg #: 1935627
·
FEI: 1935627
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SURGICAL INSTRUMENT MANUFACTURERS, LLC
- Registration Number
- 1935627
- FEI Number
- 1935627
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2076 Fenton Logistics Park
- City
- FENTON
- State
- MO
- ZIP
- 63026
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140238
Owner / Operator
- Firm Name
- SURGICAL INSTRUMENT MANUFACTURERS, LLC
- Operator Number
- 1935627
- Address
- 2076 Fenton Logistics Park Blvd., --
- City
- Fenton
- State
- MO
- Postal Code
- 63026
- Country
- US
- Correspondent
- Steve Gordon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-12-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-12-09 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-12-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-12-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-12-09 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)