FDA Registration
Active
🇺🇸 United States
QUALITY TECH SERVICES, LLC
Reg #: 3003477135
·
FEI: 3003477135
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- QUALITY TECH SERVICES, LLC
- Registration Number
- 3003477135
- FEI Number
- 3003477135
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10525 Hampshire Ave. S.
- City
- Bloomington
- State
- MN
- ZIP
- 55438
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142591
Owner / Operator
- Firm Name
- QUALITY TECH SERVICES, LLC
- Operator Number
- 9047880
- Address
- 10525 Hampshire Ave. S., --
- City
- Bloomington
- State
- MN
- Postal Code
- 55438
- Country
- US
- Correspondent
- Dawn Luehrs
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-16 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-11-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-11-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-11-16 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-11-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)