FDA.reportPublic FDA data

SpineKure Kyphoplasty System

Primary DI
08809300542966
Brand
SpineKure Kyphoplasty System
Company
HAN CHANG CO., LTD
Model
Cement Delivery System (SCDS)
Device 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).
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172871000SpineKure Kyphoplasty SystemHanchang Co., Ltd.2018-05-29NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809300542966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809300542966088093005429668809300542966

GMDN Terms#

Term, Definition table
TermDefinition
Stomal appliance cementA substance intended to be used to bind a stomal appliance, typically a tube (e.g., a colostomy or ileostomy tube) used in an operation to create a channel from an area inside the body to the outside, to the walls of a stoma (surgically-created opening in the body). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690024786
Device count
1
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809300542959SpineKure Kyphoplasty SystemBalloon Inflator (SBI)2020-04-17
08809300542928SpineKure Kyphoplasty SystemBalloon Catheter (SBC-10)2020-04-17
08809300542935SpineKure Kyphoplasty SystemBalloon Catheter (SBC-15)2020-04-17
08809300542942SpineKure Kyphoplasty SystemBalloon Catheter (SBC-20)2020-04-17
08809300542973SpineKure Kyphoplasty System SpineKure Kyphoplasty System 2020-04-17

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08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
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