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Astura Medical, LLC

USA · Irving

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

19listed device types

Class I 2Class II 17Class III 0

plus 31 registration records and 29 510(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

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 States31 registration records, 29 510(k), 0 PMA

Manufacturer names merged into this page: Astura Medical

FDA 510(k) clearances by year

42016

22017

52018

32019

32020

12021

12022

52023

22024

22025

12026

FDA listed device types

showing 8 of 19

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252885	OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System	2026-01-22
US	K252346	OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System	2025-10-21
US	K243259	MASADA Modular Spinal Fixation System	2025-01-07

Astura Medical, 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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