ALDEN TOOL COMPANY, INC.

FDA Device Registration & Listing · Berlin, CT, US · Registration 3003525643

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
3003525643
FEI Number
3003525643
Entity Name
ALDEN TOOL COMPANY, INC.
City/State/Country
Berlin, CT, US
Establishment Address
199 New Park Dr, Berlin, CT 06037, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Alden Tool Company, Inc. (Owner Number: 10043828)
Owner / Operator Contact Address
199 New Park Drive, Berlin, CT 06037, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-02
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-03-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2013-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-03-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-02
PGM Growing Rod System Orthopedic Class 2 888.3070 2026-03-02
HTO Reamer Orthopedic Class 1 888.4540 2013-03-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-03-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-02
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-03-02
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2026-03-02

Official Correspondent

John Killeen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alden Tool Company, 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
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
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
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003525643. Last updated year: 2026. Please use registration number 3003525643 when referencing this establishment in official correspondence.
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