FDA Registration
Active
🇺🇸 United States
LOWELL,INC.
Reg #: 2134470
·
FEI: 3002462840
·
Expires 2026
Products
24
Proprietary Names
17
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- LOWELL,INC.
- Registration Number
- 2134470
- FEI Number
- 3002462840
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9425 83RD AVE. N.
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
Owner / Operator
- Firm Name
- Lowell Inc.
- Operator Number
- 9034888
- Address
- 9425 83RD AVE. N., --
- City
- Minneapolis
- State
- MN
- Postal Code
- 55445
- Country
- US
- Correspondent
- Jack - Wieland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-16 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-16 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-01-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-01-16 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-12-31 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-16 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-06-23 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2020-01-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2019-12-31 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-16 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-16 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2014-09-17 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2014-07-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2020-06-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2020-06-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-06-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-01-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-01-16 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-09-17 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2014-09-17 |
Proprietary Names
Adjustable Bridge
Mosaic
Nakoma-SL
Resolute Facet Screw
Gibralt Cap
Mercury
Occipital Plate Assembly
Polyaxial Screwdriver
Anterior Cervical Plate
Gibralt Cross Connector
Tempus
Polyaxial Screw Assembly
Polyaxial Screw
Pedical Bolt
Lucent Magnum
Altius
Quantum ACP
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)