MedtechSourcebook

ALDEN TOOL COMPANY, INC.

Contract manufacturer · Berlin, CT

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3003525643 (openFDA record; or search FDA's registration database)
FEI number
3003525643
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Alden Tool Company, Inc. (FDA owner/operator no. 10043828)
Registered address
199 New Park Dr, Berlin, CT 06037
Contract listings
33 device listings, 28 product codes, first listed Mar 26, 2013
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 codeDevice (FDA name)ClassCategoryRoleFirst listed
FZTCutter, SurgicalClass IGeneral and plastic surgeryContract manufacturingMar 26, 2013
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingMar 2, 2026
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingMar 2, 2026
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract manufacturingMar 2, 2026
HTNWasher, Bolt NutClass IIOrthopedicContract manufacturingMar 2, 2026
HTOReamerClass IOrthopedicContract manufacturingMar 26, 2013
HTRRaspClass IGeneral and plastic surgeryContract manufacturingAug 21, 2015
HTWBit, DrillClass IOrthopedicContract manufacturingMar 26, 2013
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingMar 2, 2026
HXIPasser, Wire, OrthopedicClass IOrthopedicContract manufacturingMar 7, 2023
JDSNail, Fixation, BoneClass IIOrthopedicContract manufacturingMar 2, 2026
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass IIOrthopedicContract manufacturingMar 2, 2026
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingMar 2, 2026
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingMar 2, 2026
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMar 26, 2013
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass IIOrthopedicContract manufacturingMar 2, 2026
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingMar 2, 2026
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingMar 2, 2026
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingMar 2, 2026
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingMar 2, 2026
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingMar 2, 2026
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingMar 2, 2026
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingMar 2, 2026
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingMar 2, 2026
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingMar 2, 2026
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingMar 2, 2026
PGMGrowing Rod SystemClass IIOrthopedicContract manufacturingMar 2, 2026
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingMar 2, 2026