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ALPHATEC SPINE, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 6 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

75listed device types

Class I 42Class II 32Class III 0unclassified 1

plus 297 registration records and 101 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

26registered devices

Class I 24Class II 2

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

6valid device licences

Class II 4Class III 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

74active ARTG entries

Class I 47IIa 14IIb 9Class Im (measuring) 3Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States297 registration records, 101 510(k), 0 PMA, 2 excluded

Brazil26 confirmed, 0 excluded

Manufacturer names merged into this page: ALPHATEC SPINE, INC. · Alphatec Spine, Inc. · ALPHATEC SPINE INC · ALPHATEC SPINE INC.

FDA 510(k) clearances by year

52007

32008

62009

42010

42011

22012

42013

12014

32015

42016

12017

72018

62019

72020

62021

82022

112023

72024

52025

52026

FDA listed device types

showing 8 of 75

Electrode, Needle 1Posterior Cervical Screw System 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Electromyograph, Diagnostic 1Neurosurgical Nerve Locator 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261284	Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System	2026-07-14
US	K253216	IntraOp Alignment System; CONTOUR3D Bending System	2026-06-25
US	K253615	Invictus Bands System	2026-03-25
BR	80263050024	Iluminador Cirúrgico para Sistema Transpedicular Alphatec Spine	Class I
BR	80263050016	CAIXAS E PARTES PARA ACOMODAÇÃO DE IMPLANTES E INSTRUMENTAIS ALPHATEC	Class I
BR	80263050017	CAIXAS E PARTES PARA ACOMODAÇÃO DE IMPLANTES E INSTRUMENTAIS SCIENT'X	Class I

ALPHATEC SPINE, 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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