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SPINAL ELEMENTS, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

29listed device types

Class I 4Class II 24Class III 0unclassified 1

plus 103 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 16Class II 12

29 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States103 registration records, 50 510(k), 0 PMA, 3 excluded

Brazil28 confirmed, 1 excluded

Manufacturer names merged into this page: SPINAL ELEMENTS, INC. · SPINAL ELEMENTS, INC. (CARLSBAD)

FDA 510(k) clearances by year

42007

52008

42009

12010

32012

32013

22014

32015

32016

12017

42018

32019

22020

22021

12022

32023

12024

22025

32026

FDA listed device types

showing 8 of 29

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Neurological Stereotaxic Instrument 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260506	Ventana® P/T Lumbar Interbody System	2026-05-15
US	K253559	Ventana A Anterior Lumbar Interbody System	2026-02-25
US	K250773	Luna® Ti Interbody Fusion System	2026-02-04
BR	10355870236	Instrumentos Spinal Elements PPSU	Class I
BR	10355870247	Instrumentos Spinal Elements NANC	Class I
BR	10355870229	INSTRUMENTOS SPINAL ELEMENTS NANC 304L/316L	Class I

SPINAL ELEMENTS, INC.

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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