Medical Device Division · registration 190251Active

Medtronic Sofamor Danek USA

Name: Medtronic Sofamor Danek USA — Medical Device Division 190251
Creator: Medtronic Sofamor Danek USA, Inc.
Keywords: Medtronic Sofamor Danek USA, Medtronic Sofamor Danek USA, 190251, Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty, Medical Device Division

Hong KongProcedure Kit/Trays, Spinal Surgery, Kyphoplasty/VertebroplastyClass IIIMedtronic Sofamor Danek USA, Inc.

Verified

Official record identity

MDACS listing number: 190251
Model name: KyphoPak Tray, KYPHON Xpander II 15/3 Inflatable Bone Tamp, First Fracture with KYPHON Osteo Introducer System (KPX153RB), KYPHON Xpander II Inflatable Bone Tamp, 10/3 (KX103), KYPHON Xpander II Inflatable Bone Tamp, 15/3 (KX153), KYPHON Xpander II Inflatable Bone Tamp, 20/3 (KX203), Bone Filler Device. Size 3 (F04B), KYPHON Directional Bone Filler Device (F04C), KYPHON Bone Biopsy Device. size 3 (F05A), KYPHON One Step Osteo Introducer System, Trocar and Diamond, size 3 (T15J), KYPHON Mixer (A07A), KYPHON Xpede Bone Cement and KYPHON Mixer Pack (CX01B), KYPHON HV-R Bone Cement (C01A), KYPHON CDS Cement Cartridges (CC02A), KYPHON Cement Delivery Gun and Bone Filler Device Size 2 (CDS2A), KYPHON Cement Delivery Gun and Bone Filler Device Size 3 (CDS3A), KYPHON Inflation Syringe (A08E), KYPHON Multi-tap Adapter. Size 3 (A23), Kyphon V 11ga Trocar Bevel Tip (VPT11D), Kyphon V 13ga Trocar Bevel Tip (VPT13D)
Registration date: July 26, 2024
Expiry date: July 25, 2029
Source update date: November 05, 2024
Status: Active

Classification

Risk class: Class III
Published category: Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty

Published parties

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

Official description

Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty

Additional source fields

AMD nomenclature code: 32908
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, TN 38132, USA
Revision number: a

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.