190251
III
current
Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty手术套件/托盘, 脊柱手术, 脊柱后凸成形术/椎体成形术
This profile provides complete Hong Kong MDACS registration information for Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty
產品資訊： 手术套件/托盘, 脊柱手术, 脊柱后凸成形术/椎体成形术
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
32908
Product Code Detail
32908 Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty
State
current
Status
N/A
Manufacturer (製造商)
Medtronic Sofamor Danek USA, Inc.
Medtronic Plc
United States
美国
1800 Pyramid, TN 38132, USA
1800金字塔, TN 38132, 美国
Authorised Representative (AR)
Regulatory Timeline
Registration Date
July 26, 2024
Expiry Date
July 25, 2029
Product Models
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)
KyphoPak 托盘,KYPHON Xpander II 15/3 充气骨夯实,首次骨折与 KYPHON Osteo介绍系统 (KPX153RB),KYPHON Xpander II 充气骨夯,10/3 (KX103),KYPHON Xpander II 充气骨夯,15/3 (KX153),KYPHON Xpander II 充气骨夯,20/3 (KX203),骨填充装置.尺寸 3 (F04B),KYPHON 定向骨填充装置 (F04C),KYPHON 骨活检装置.尺寸 3 (F05A), KYPHON 一步法骨介绍系统, 穿刺器和钻石, 尺寸 3 (T15J), KYPHON 搅拌机 (A07A), KYPHON Xpede 骨水泥和 KYPHON 搅拌机包 (CX01B), KYPHON HV-R 骨水泥 (C01A), KYPHON CDS 水泥滤芯 (CC02A), KYPHON 水泥输送枪和骨填充装置尺寸 2 (CDS2A), KYPHON 水泥输送枪和骨填料设备尺寸 3 (CDS3A), KYPHON充气注射器(A08E),KYPHON多抽头适配器.尺寸 3 (A23), Kyphon V 11ga 穿刺器斜面尖端 (VPT11D), Kyphon V 13ga 穿刺器斜面尖端 (VPT13D)