SpineKure Kyphoplasty System

GUDID 08809300542935

The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).

HAN CHANG CO., LTD

Inflatable bone tamp
Primary Device ID08809300542935
NIH Device Record Key90f7e1f8-33b8-4b42-a2de-b0ce554d0247
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineKure Kyphoplasty System
Version Model NumberBalloon Catheter (SBC-15)
Company DUNS690024786
Company NameHAN CHANG CO., LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809300542935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-27
Device Publish Date2020-04-17

On-Brand Devices [SpineKure Kyphoplasty System]

08809300542973The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s
08809300542966The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s
08809300542959The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s
08809300542942The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s
08809300542935The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s
08809300542928The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore s

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