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Sofamor Danek Mfg., Inc.

USA · Memphis

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

144listed device types

Class I 62Class II 53Class III 28unclassified 1

plus 902 registration records and 503 510(k), 240 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

100registered devices

Class I 35Class II 65

130 including historic records

SASaudi ArabiaSFDA

248registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

22active device licences

Class II 4Class III 18

134 including historic records

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 States902 registration records, 503 510(k), 240 PMA, 2 excluded

Brazil100 confirmed, 0 excluded

Saudi Arabia248 confirmed, 0 excluded

Canada22 confirmed, 0 excluded

Manufacturer names merged into this page: MEDTRONIC SOFAMOR DANEK USA, INC. · MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH · MEDTRONIC SOFAMOR DANEK USA, INC · MEDTRONIC SOFAMOR DANEK, INC. · MEDTRONIC SOFAMOR DANEK MANUFACTURING · Medtronic Sofamor Danek USA Inc.

Same-named companies — This database also contains companies with near-identical names: Medtronic Sofamor Danek, Inc., MEDTRONIC SOFAMOR DANEK MANUFACTURING, Medtronic Sofamor Danek USA, Incorporated, Sofamor Danek. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

162007

212008

172009

142010

192011

162012

262013

202014

202015

132016

142017

92018

122019

72020

82021

62022

52023

42024

72025

62026

FDA listed device types

showing 8 of 144

Electrosurgical, Cutting & Coagulation & Accessories 1Posterior Cervical Screw System 1Electrode, Needle 1Bone Grafting Material, Animal Source 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Posterior Metal/Polymer Spinal System, Fusion 1Intervertebral Fusion Device With Bone Graft, Lumbar 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253011	Catalyft PL Expandable Interbody System	2026-07-17
US	K261020	Symmetrix L Spinal System	2026-07-14
US	K253656	OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System	2026-06-05
BR	10349001334	Instrumentos reutilizáveis da Solera FNS	Class I
BR	10349001337	Instrumentos Reutilizáveis Radel	Class I
BR	10349000605	INSTRUMENTAIS PARA CIRURGIA DE COLUNA CD HORIZON	Class I
SA	ME0000000280SFDAA00243	CD Horizon Solera 5.5/6.0 lg rod tray	—
SA	ME0000000280SFDAA00249	5.5/6.0 ROD PUSHER	—
CA	5058	COLORADO SPINAL SYSTEM	Class III
CA	11945	AXIS FIXATION SYSTEM	Class III
CA	11957	GDLH POSERIOR SPINAL SYSTEM	Class III

Sofamor Danek Mfg., 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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