Data / Medical devices / United States / Spinal Simplicity, LLC
Spinal Simplicity, LLC: FDA-registered device maker in Overland Park, KS, United States, 12 510(k) clearances
Spinal Simplicity, LLC is registered with the FDA (registration 3009704301) in Overland Park, KS, United States. It lists 10 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009704301
- Address
- 6363 College Blvd Suite 320, Overland Park, KS, United States, 66211
- Owner or operator
- Spinal Simplicity, LLC (10041761)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 29, 2012
- Registered through
- 2026
- Brand names listed
- Edge Upper Cervical System, Freedom DS Decompression System, G-2 Inserter, G1 Minuteman, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate, Instrument Surgical Tray, Liberty SI Lateral Implant System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2026 | K253523 | Freedom DS Decompression System | HRX | Substantially Equivalent | Spinal Simplicity | accessdata.fda.gov |
| December 1, 2025 | K253250 | Minuteman® G6 MIS Fusion Plate | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| May 24, 2024 | K240592 | Wolff's Law Anterior Cervical Plate System | KWQ | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| April 19, 2024 | K232259 | Patriot-SI Posterior Implant System | OUR | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| January 18, 2024 | K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| December 5, 2023 | K231923 | Liberty SI Lateral Implant System | OUR | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| July 10, 2023 | K221307 | Edge Upper Cervical System | NKG | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| March 11, 2022 | K211880 | Minuteman G5 MIS Fusion Plate | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| December 10, 2020 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| February 2, 2017 | K163428 | HA Minuteman G3-R MIS Fusion Plate | PEK | Substantially Equivalent | Spinal Simplicity | accessdata.fda.gov |
| August 20, 2015 | K151741 | HA Minuteman G3 MIS Fusion Plate | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
| January 9, 2015 | K140046 | SPINOUS PROCESS FUSION (SPF) PLATE | PEK | Substantially Equivalent | Spinal Simplicity, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Spinous Process Plate
- All makers of Rongeur, Manual
- All makers of Arthroscope
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Posterior Cervical Screw System
- All makers of Sacroiliac Joint Fixation
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.