SpineKure Kyphoplasty System

GUDID 08809300542959

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

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08809300542959
• NIH Device Record Key: 76ccc849-24fe-44a2-8232-15ed952ee9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineKure Kyphoplasty System
• Version Model Number: Balloon Inflator (SBI)
• Company DUNS: 690024786
• Company Name: HAN CHANG CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809300542959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172871

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-17

On-Brand Devices [SpineKure Kyphoplasty System]

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