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Trans1 Incorporated

USA · Magnolia

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 3 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

8listed device types

Class I 2Class II 5Class III 0unclassified 1

plus 10 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

2registrations

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 States10 registration records, 14 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: TranS1 · TranS1 Inc.

FDA 510(k) clearances by year

22004

22005

32008

22010

12011

12012

12013

22019

FDA listed device types

Orthopedic Manual Surgical Instrument 1Accessories, Arthroscopic 1System, Facet Screw Spinal Device 1Staple, Fixation, Bone 1Appliance, Fixation, Spinal Intervertebral Body 1Pin, Fixation, Smooth 1Arthroscope 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192792	TranS1 AxiaLIF Plus System	2019-11-20
US	K191791	TranS1 Interbody Fusion System	2019-09-25
US	K123997	TRANS1LATERAL INTERBODY FUSION SYSTEM	2013-04-01
BR	10355870139	KIT INSTRUMENTAL REUTILIZÁVEL AXIALIF 2 LEVE PLUS	Class I
BR	10355870138	CORTADOR DE DISCO AXIALIF	Class II
BR	10355879009	INSTRUMENTOS AXIALIF 2L PLUS	Class I

Trans1 Incorporated

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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