Contract manufacturerINSERT MOLDING SOLUTIONS, INC. (Cumming, GA)GeorgiaAnesthesiologyEar, nose and throatNeurologyPhysical medicineGeneral hospitalGastroenterology and urologyOrthopedicClass II
INSERT MOLDING SOLUTIONS, INC.
Contract manufacturer ยท Cumming, GA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | Class II | Anesthesiology | Contract manufacturing | Jan 15, 2025 |
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | Anesthesiology | Contract manufacturing | Jan 15, 2025 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Jun 7, 2013 |
| GWF | Stimulator, Electrical, Evoked Response | Class II | Neurology | Contract manufacturing | Jan 15, 2025 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 15, 2025 |
| IKN | Electromyograph, Diagnostic | Class II | Physical medicine | Contract manufacturing | Jan 15, 2025 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Jan 15, 2025 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Apr 24, 2020 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 15, 2025 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| PDQ | Neurosurgical Nerve Locator | Class II | Ear, nose and throat | Contract manufacturing | Jan 15, 2025 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |
| PML | Bone Cement, Posterior Screw Augmentation | Class II | Orthopedic | Contract manufacturing | Jan 15, 2025 |