# Spinal Simplicity, LLC

- Location (FDA's records): Overland Park, KS
- FDA decisions: 17 (2015–2026): 17 510(k) clearances
- Names in FDA's records: Spinal Simplicity, LLC (15); Spinal Simplicity (2)
- Product codes: PEK (11), OUR (3), NKG (1), KWQ (1), HRX (1)
- 510(k) review time since 2016: median 153 days, against 84 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 35 (20 its own); citations of its devices by later devices: 20 (20 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Ilion Medical, Inc.: 1 (https://510kreport.com/company/ilion-medical)
- Ulrich GmbH & Co. KG: 1 (https://510kreport.com/company/ulrich)
- Lanx, Inc.: 1 (https://510kreport.com/company/lanx)
- X-Spine Systems, Inc.: 1 (https://510kreport.com/company/x-spine-systems)
- Aurora Spine, Inc.: 1 (https://510kreport.com/company/aurora-spine)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K140046: Spinous Process Fusion (SPF) Plate (2015), cited by 4
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), cited by 4
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), cited by 3
- K212781: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (2021), cited by 2
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), cited by 2
- K232259: Patriot-SI Posterior Implant System (2024), cited by 1

## Recent decisions
- K261607: Minuteman G6 MIS Fusion Plate; 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; Patriot SI Implant System; Liberty SI Lateral Implant System (Oct 2, 2026)
- K253523: Freedom DS™ Decompression System (Apr 16, 2026)
- K253250: Minuteman® G6 MIS Fusion Plate (Dec 1, 2025)
- K250001: Patriot SI Implant System (Jun 3, 2025)
- K240592: Wolff's Law Anterior Cervical Plate System (May 24, 2024)
- K232259: Patriot-SI Posterior Implant System (Apr 19, 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 (Jan 18, 2024)
- K231923: Liberty SI Lateral Implant System (Dec 5, 2023)

Source page: https://510kreport.com/company/spinal-simplicity