Medical Device Division · registration 210490Active

Medtronic Sofamor Danek USA

Name: Medtronic Sofamor Danek USA — Medical Device Division 210490
Creator: Medtronic Sofamor Danek USA, Inc.
Keywords: Medtronic Sofamor Danek USA, Medtronic Sofamor Danek USA, 210490, Orthopedic Internal Fixation Systems, Spinal, Medical Device Division

Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIMedtronic Sofamor Danek USA, Inc.

Verified

Official record identity

MDACS listing number: 210490
Model name: SOVEREIGN Spinal System (1850078, 1850079, 1850095, 1850460, 1858711, 7960080, 7960081, 79614210, 79614212, 79614214, 79614216, 79614218, 79614220, 79614810, 79614812, 79614814, 79614816, 79614818, 79614820, 79615210, 79615212, 79615214, 79615216, 79615218, 79615220, 79615810, 79615812, 79615814, 79615816, 79615818, 79615820, 79616210, 79616212, 79616214, 79616216, 79616218, 79616220, 79616810, 79616812, 79616814, 79616816, 79616818, 79616820, 7965520, 7965525, 7965530, 7965535, 7966020, 7966025, 7966030, 7966035, 7967003, 7967005, 7967010, 7967011, 7967012, 7967016, 7967018, 7967021, 7967022, 7967023, 7967028, 7967041, 7967060, 7967061, 7967062, 7967069, 7967073, 7967074, 7967075, 7967079, 7967080, 7967081, 7967082, 7967083, 7967085, 7967086, 7967088, 7967089, 7967095, 7967096, 7967097, 7967098, 7967210, 7967212, 7967214, 7967216, 7967218, 7967220, 7967810, 7967812, 7967814, 7967816, 7967818, 7967820, 7968210, 7968212, 7968214, 7968216, 7968218, 7968220, 7968810, 7968812, 7968814, 7968816, 7968818, 7968820, 7969000, 7969001, 7969002, 7969004, 7969006, 7969007, 7969210, 7969212, 7969214, 7969216, 7969218, 7969220, 7969810, 7969812, 7969814, 7969816, 7969818, 7969820, 7975520, 7975525, 7975530, 7975535, 7976020, 7976025, 7976030, 7976035, 7980067, 7980068, 9010002000, 9010002001, 9010002002, 9010002003, 9010002004, 9010002005, 9010002006, 9010002007, 9010002008, 9010002009, 9010002015, 9010002016, 9010002017, 9010002018, 9010002019, 9010002020, 9010002021, 9010002022, 9010002023, 9010002024, 9010002030, 9010002031, 9010002032, 9010002033, 9010002034, 9010002035, 9010002036, 9010002037, 9010002038, 9010002039, 9010002050, 9010002051, 9010002052, 9010002053, 9010002054, 9010002055, 9010002056, 9010002057, 9010002058, 9010002059, 9010002065, 9010002066, 9010002067, 9010002068, 9010002069, 9010002070, 9010002071, 9010002072, 9010002073, 9010002074, 9010002080, 9010002081, 9010002082, 9010002083, 9010002084, 9010002085, 9010002086, 9010002087, 9010002088, 9010002089, 9339082, 9870011)
Registration date: December 03, 2021
Expiry date: December 03, 2026
Source update date: July 07, 2023
Status: Active

Classification

Risk class: Class III
Published category: Orthopedic Internal Fixation Systems, Spinal

Published parties

Registrant / registration holder: Medtronic Hong Kong Medical Limited
Manufacturer: Medtronic Sofamor Danek USA, Inc.

Official description

Orthopedic Internal Fixation Systems, Spinal

Additional source fields

AMD nomenclature code: 15766
Traditional Chinese local responsible person: 美敦力香港醫療有限公司
Local responsible person phone: 29191300
Published manufacturer address: 1800 Pyramid Place Memphis, TN 38132, USA

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.