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Medtronic Spine, LLC

USA · Sunnyvale

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 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

30listed device types

Class I 15Class II 15Class III 0

plus 43 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

0valid device licences

SGSingaporeHSA SMDR

9device registrations

CLASS B 8CLASS C 1

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 States43 registration records, 2 510(k), 0 PMA, 114 excluded

Brazil8 confirmed, 36 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 24 excluded

Manufacturer names merged into this page: Titan Spine, a Division of Medtronic · MEDTRONIC SPINE LLC

Same-named companies — This database also contains companies with near-identical names: Titan Spine, Inc., Titan Spine, a Division of Medtronic. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103231	KYPHON INFLATION SYRINGE	2011-01-24
US	K101765	KYPHON ANCHOR FACET SCREW SYSTEM	2010-10-22
BR	10355870195	CURETA KYPHON LATITUDE II	Class II
BR	10355870196	KIT CÂNULA DE ENCHIMENTO ÓSSEO KYPHON	Class II
BR	10355870197	KIT CÂNULA KPT	Class II

Medtronic 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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