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Manufacturer profile

Medtronic Sofamor Danek USA Inc

Manufacturer • United States of America282 devices on the TGA ARTG6 device classesSep 17, 2003 – Dec 23, 2024
VerifiedTGA · Australian Register of Therapeutic Goods
282
Total devices
6
Device classes
2003
Earliest registration
2024
Latest registration
Regulatory footprint
Search Medtronic Sofamor Danek USA Inc across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Recent device registrations
Latest 10 TGA ARTG device registrations
Orthopaedic cement dispensing gun
ARTG 474510Sponsor: Medtronic Australasia Pty Ltd
Class I · Dec 23, 2024
Orthopaedic cement dispensing gun
ARTG 474510Sponsor: Medtronic Australasia Pty Ltd
Class I · Dec 23, 2024
Bone graft funnel
ARTG 474469Sponsor: Medtronic Australasia Pty Ltd
Class I · Dec 23, 2024
Bone graft funnel
ARTG 474469Sponsor: Medtronic Australasia Pty Ltd
Class I · Dec 23, 2024
Spinal cage
ARTG 437270Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Jan 24, 2024
Spinal cage
Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Jan 24, 2024
Bone-screw internal spinal fixation system, sterile
ARTG 422155Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Sep 21, 2023
Bone-screw internal spinal fixation system, sterile
ARTG 422154Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Sep 21, 2023
Bone-screw internal spinal fixation system, sterile
Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Sep 21, 2023
Bone-screw internal spinal fixation system, non-sterile
Sponsor: Medtronic Australasia Pty Ltd
Class IIb · Sep 21, 2023
View all 282 devices →
Risk class distribution
Devices by risk class
Class I15856.0% of total
Class IIa3813.5% of total
Class IIb5820.6% of total
Class III124.3% of total
Class Is20.7% of total
Class Im145.0% of total
About this profile

Explore comprehensive manufacturer profile for Medtronic Sofamor Danek USA Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 282 medical devices registered with TGA ARTG across 6 device classes. This manufacturer is based in United States of America. Their registration history spans from Sep 17, 2003 to Dec 23, 2024.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIa: 38, Class I: 158, Class IIb: 58, Class Im: 14, Class III: 12, Class Is: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's medical device registry with 62k records.