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SPINAL SIMPLICITY, LLC

USA · Overland Park

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 3Class II 7Class III 0

plus 16 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States16 registration records, 16 510(k), 0 PMA, 3 excluded

Manufacturer names merged into this page: SPINAL SIMPLICITY, LLC · SPINAL SIMPLICITY LLC

FDA 510(k) clearances by year

22015

12017

12020

12021

22022

32023

32024

22025

12026

FDA listed device types

showing 8 of 10

Posterior Cervical Screw System 1Rongeur, Manual 1Appliance, Fixation, Spinal Intervertebral Body 1Arthroscope 1Spinous Process Plate 1Sacroiliac Joint Fixation 1Appliance, Fixation, Spinal Interlaminal 1Instrument, Manual, Surgical, General Use 1

Market	Identifier	Name	Class / date
US	K253523	Freedom DS Decompression System	2026-04-16
US	K253250	Minuteman® G6 MIS Fusion Plate	2025-12-01
US	K250001	Patriot SI Implant System	2025-06-03

SPINAL SIMPLICITY, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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