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SpineKure Kyphoplasty System

FDA UDI

Class II (US FDA UDI)

by Hanchang Co., Ltd.

Identity

Trade Name
SpineKure Kyphoplasty System FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
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). FDA UDI
Model / Reference
Balloon Inflator (SBI) FDA UDI
Description
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). FDA UDI

Identifiers

Primary DI / UDI-DI
08809300542959 FDA UDI
510(k) Number
K172871 FDA UDI
FDA Product Code
NDN FDA UDI
HRX FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

SpineKure Kyphoplasty System by Hanchang Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Cleared under the same submission

K172871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hanchang Co., Ltd.

Sources (1)

  • FDA UDI 76ccc849-24fe-44a2-8232-15ed952ee9e0 34 fields · synced Jun 1, 2026