Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009704301

FEI Number

3009704301

Entity Name

SPINAL SIMPLICITY, LLC

City/State/Country

Overland Park, KS, US

Establishment Address

6363 College Blvd, Suite 320, Overland Park, KS 66211, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Spinal Simplicity, LLC (Owner Number: 10041761)

Owner / Operator Contact Address

6363 College Blvd, Suite 320, Overland Park, KS 66211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221307

PMA Number

N/A

All Registered Proprietary Names

Liberty SI Lateral Implant System Freedom DS Decompression System G1 Minuteman Minuteman G5 Mis Fusion Plate; Minuteman G1(Posterior Fusion Plate /Ha Posterior Fusion Plate); Ha Minuteman G3-R Mis Fu Minuteman G5 Minuteman G6 MIS Fusion Plate Instrument Surgical Tray Patriot SI Surgical Instruments Liberty SI Surgical Instruments Minuteman Surgical Instruments Wolff's Law Anterior Cervical Plate System Minuteman G1 Minuteman G3 Edge Upper Cervical System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-12-20
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2026-04-29
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-04-29
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2018-07-03
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2024-06-21
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2022-04-07
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-12-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-12-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-11-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-21
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2020-12-14
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2015-02-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-06
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-12-06

Official Correspondent

Adam Rogers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spinal Simplicity, LLC

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
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009704301. Last updated year: 2026. Please use registration number 3009704301 when referencing this establishment in official correspondence.