Contract manufacturerLOWELL,INC. (Brooklyn Park, MN)MinnesotaCardiovascularEar, nose and throatNeurologyOrthopedicGeneral hospitalClass IIIClass IIUnclassified
LOWELL,INC.
Contract manufacturer ยท Brooklyn Park, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2134470 (openFDA record; or search FDA's registration database)
- FEI number
- 3002462840
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Lowell Inc. (FDA owner/operator no. 9034888)
- Registered address
- 9425 83RD AVE. N., Brooklyn Park, MN 55445
- Contract listings
- 54 device listings, 24 product codes, first listed Jul 14, 2014
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | Class III | Cardiovascular | Contract manufacturing | Jan 28, 2020 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Jan 16, 2025 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 16, 2025 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 16, 2025 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 16, 2025 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jun 23, 2020 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Jan 16, 2025 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jun 23, 2020 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jun 23, 2020 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Jun 23, 2020 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Sep 17, 2014 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Sep 17, 2014 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Dec 31, 2019 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | Contract manufacturing | Jul 14, 2014 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 16, 2025 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 31, 2019 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Nov 6, 2014 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Sep 17, 2014 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Sep 17, 2014 |