LOWELL,INC.

FDA Device Registration & Listing · Brooklyn Park, MN, US · Registration 2134470

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2134470
FEI Number
3002462840
Entity Name
LOWELL,INC.
City/State/Country
Brooklyn Park, MN, US
Establishment Address
9425 83RD AVE. N., Brooklyn Park, MN 55445, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Lowell Inc. (Owner Number: 9034888)
Owner / Operator Contact Address
9425 83RD AVE. N., --, Minneapolis, MN 55445, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Adjustable Bridge Mosaic Nakoma-SL Resolute Facet Screw Gibralt Cap Mercury Occipital Plate Assembly Polyaxial Screwdriver Mercury Anterior Cervical Plate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-10-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-10-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-11-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-11-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-11-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-11-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-11-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-31
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2014-09-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-11-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-23
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2020-01-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-12-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2014-09-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-10-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-10-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2014-07-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-07-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-07-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-07-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-07-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-12-19
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-12-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-09-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-09-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-09-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-09-17
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-04-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-07-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-07-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-07-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-11-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-11-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-11-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-10-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-10-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-10-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-09-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-09-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-09-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-09-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-09-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-09-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-09-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-09-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-07-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-01-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2020-06-23
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2020-06-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-06-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-07-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-11-06
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-12-20

Official Correspondent

Jack Wieland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lowell Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134470. Last updated year: 2026. Please use registration number 2134470 when referencing this establishment in official correspondence.
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