MedtechSourcebook

INSERT MOLDING SOLUTIONS, INC.

Contract manufacturer ยท Cumming, GA

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

2013Product codes first listed, by year (tallest: 17)2026
FDA registration
3009050824 (openFDA record; or search FDA's registration database)
FEI number
3009050824
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Insert Molding Solutions, Inc. (FDA owner/operator no. 10044415)
Registered address
4325 Settingdown Cir Ste 103, Cumming, GA 30028
Contract listings
20 device listings, 19 product codes, first listed Jun 7, 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
BSKCuff, Tracheal Tube, InflatableClass IIAnesthesiologyContract manufacturingJan 15, 2025
BTRTube, Tracheal (W/Wo Connector)Class IIAnesthesiologyContract manufacturingJan 15, 2025
ETNStimulator, NerveClass IIEar, nose and throatContract manufacturingJun 7, 2013
GWFStimulator, Electrical, Evoked ResponseClass IINeurologyContract manufacturingJan 15, 2025
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingJan 15, 2025
IKNElectromyograph, DiagnosticClass IIPhysical medicineContract manufacturingJan 15, 2025
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass IIGeneral hospitalContract manufacturingJan 15, 2025
KNWInstrument, BiopsyClass IIGastroenterology and urologyContract manufacturingApr 24, 2020
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingJan 15, 2025
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingJan 15, 2025
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingJan 15, 2025
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingJan 15, 2025
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingJan 15, 2025
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingJan 15, 2025
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingJan 15, 2025
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingJan 15, 2025
PDQNeurosurgical Nerve LocatorClass IIEar, nose and throatContract manufacturingJan 15, 2025
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingJan 15, 2025
PMLBone Cement, Posterior Screw AugmentationClass IIOrthopedicContract manufacturingJan 15, 2025