Insert Molding Solutions, Inc.
Cumming, GA, US
INSERT MOLDING SOLUTIONS, INC. appears in FDA device records in Cumming, GA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Insert Molding Solutions, Inc. between 2011 and 2018. The busiest year on record is 2011, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172760 | REST EAZY Appliance | LRK | Substantially Equivalent | |
| K111529 | MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- | KNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009050824 | 3009050824 | INSERT MOLDING SOLUTIONS, INC. | 4325 Settingdown Cir Ste 103, Cumming, GA 30028 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PMLBone Cement, Posterior Screw Augmentation
- BSKCuff, Tracheal Tube, Inflatable
- LRKDevice, Anti-Snoring
- IKNElectromyograph, Diagnostic
- KNWInstrument, Biopsy
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- HAWNeurological Stereotaxic Instrument
- PDQNeurosurgical Nerve Locator
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- NKBThoracolumbosacral Pedicle Screw System
- BTRTube, Tracheal (W/Wo Connector)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain