FDA.reportPublic FDA data

Kyphoplasty Tool Kit

Primary DI
06923558507569
Brand
Kyphoplasty Tool Kit
Company
Jiangsu Changmei Medtech Co., Ltd.
Model
KT-00-05
Device description
Kyphoplasty Tool Kit (Bilateral standard type)
Published
2025-10-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIHDispenser, Cement
LXHOrthopedic Manual Surgical Instrument
OARInjector, Vertebroplasty (Does Not Contain Cement)
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923558507569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923558507569069235585075696923558507569

GMDN Terms#

Term, Definition table
TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+008651988520118sales@czmed.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923558509693Kyphoplasty Tool KitKT-00-062025-10-23
06923558506487Balloon InflatorBI-20A-102025-10-21
06923558506968Kyphoplasty Balloon CatheterKB0120S12025-10-21
06923558507385Kyphoplasty Balloon CatheterKB0115S12025-10-21
06923558509709Kyphoplasty Balloon CatheterKB0210S12025-10-21

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B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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