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GENESYS SPINE

USA · Austin

✓ 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

26listed device types

Class I 15Class II 11Class III 0

plus 44 registration records and 31 510(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 States44 registration records, 31 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: GENESYS SPINE

FDA 510(k) clearances by year

22010

22011

22013

22014

22015

52016

32017

32018

42019

12020

12022

12023

12024

22025

FDA listed device types

showing 8 of 26

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Cervical 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Spinal Vertebral Body Replacement Device 1Orthopedic Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252322	SIros-X System	2025-10-22
US	K242483	Genesys Spine AIS-C II Cervical Interbody Fusion System	2025-02-07
US	K233595	Genesys Spine Sacroiliac Joint Fusion System with Navigation	2024-03-29

GENESYS SPINE

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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