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Nexxt Spine, LLC

USA · Noblesville

✓ 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

20listed device types

Class I 2Class II 17Class III 0unclassified 1

plus 28 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 11

13 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 States28 registration records, 24 510(k), 0 PMA, 1 excluded

Brazil11 confirmed, 0 excluded

Manufacturer names merged into this page: NEXXT SPINE LLC

FDA 510(k) clearances by year

12009

12010

12012

32013

12014

12016

12017

12018

22019

72020

22022

12023

12024

12025

FDA listed device types

showing 8 of 20

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 1Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243838	NEXXT MATRIXX® SI System	2025-03-14
US	K240690	STRUXXURE® MCS Anterior Cervical Plate System	2024-03-22
US	K231799	INERTIA® CONNEXX Modular Pedicle Screw System	2023-07-20
BR	82274000006	INSTRUMENTAIS CIRÚRGICOS NEXXT MATRIXX ALIF -SGT	Class I
BR	82274000007	INSTRUMENTAIS CIRÚRGICOS NEXXT MATRIXX LATERAL -SGT	Class I
BR	82274000008	INSTRUMENTAIS CIRÚRGICOS NEXXT MATRIXX CERVICAL -SGT	Class I

Nexxt Spine, 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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