INSERT MOLDING SOLUTIONS, INC.

FDA Device Registration & Listing · Cumming, GA, US · Registration 3009050824

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
3009050824
FEI Number
3009050824
Entity Name
INSERT MOLDING SOLUTIONS, INC.
City/State/Country
Cumming, GA, US
Establishment Address
4325 Settingdown Cir Ste 103, Cumming, GA 30028, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Insert Molding Solutions, Inc. (Owner Number: 10044415)
Owner / Operator Contact Address
4325 Settingdown Circle, Suite 103, Cumming, GA 30028, 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
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-06-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-15
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-15
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-15
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-15
BSK Cuff, Tracheal Tube, Inflatable Anesthesiology Class 2 868.5750 2025-01-15
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-15
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-15

Official Correspondent

Paul Hendrixson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Insert Molding Solutions, 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
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
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-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.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009050824. Last updated year: 2026. Please use registration number 3009050824 when referencing this establishment in official correspondence.
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