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Kyphoplasty System

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref FG0005-20Model FG0005-10, FG0005-15, FG0005-20

by Shanghai Kinetic Medical Co., Ltd.

Identity

Trade Name
Kyphoplasty System EUDAMED
KMC Kyphoplasty System FDA UDI
Generic Name
Balloon kyphoplasty kit FDA UDI
Device Name
Kyphoplasty Procedure Pack EUDAMED
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
Model / Reference
FG0005-10, FG0005-15, FG0005-20 EUDAMED
FG0005-20 EUDAMEDFDA UDI
Description
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI

Identifiers

Catalog Number
FG0005-20 FDA UDI
Primary DI / UDI-DI
06938695500144 EUDAMEDFDA UDI
Basic UDI-DI
69386955PKPV6Q EUDAMED
510(k) Number
K113742 FDA UDI
FDA Product Code
NDN FDA UDI
HRX FDA UDI
EMDN Code
P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
GMDN Term
Balloon kyphoplasty kit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
888.1100 FDA UDI
Medical Purpose
The KMC Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Kyphoplasty System by Shanghai Kinetic Medical Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Kinetic Medical Co., Ltd.
EUDAMED SRN
CN-PR-000040949

Sources (2)

  • EUDAMED 00b81540-7364-4528-9f25-bc55df37df5b 61 fields · synced Jun 7, 2026
  • FDA UDI 28f95ebb-2b24-4731-87c9-7ee3ebea01dd 37 fields · synced May 30, 2026