FDA.reportPublic FDA data

Kyphoplasty Balloon Catheter

Primary DI
06923558507385
Brand
Kyphoplasty Balloon Catheter
Company
Jiangsu Changmei Medtech Co., Ltd.
Model
KB0115S1
Device description
peanut type, balloon size 15mm, working channel greater than or equal to 3.1mm, with needle-free connector
Published
2025-10-21
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
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HXGTampOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223709000Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd.2023-08-16HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923558507385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923558507385069235585073856923558507385

GMDN Terms#

Term, Definition table
TermDefinition
Kyphoplasty balloon catheterA sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Regulatory Flags#

DUNS number
560432633
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923558507569Kyphoplasty Tool KitKT-00-052025-10-23
06923558509693Kyphoplasty Tool KitKT-00-062025-10-23
06923558506487Balloon InflatorBI-20A-102025-10-21
06923558506968Kyphoplasty Balloon CatheterKB0120S12025-10-21
06923558509709Kyphoplasty Balloon CatheterKB0210S12025-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038058163SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-22
08800038058170SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-22
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22