Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation FDA UDI
Generic Name: Balloon kyphoplasty kit FDA UDI
Device Name: 10G, 15mm One Balloon Kit/Dual Access-AFX FDA UDI
Model / Reference: VCF-1015-1ARX FDA UDI
Description: 10G, 15mm One Balloon Kit/Dual Access-AFX FDA UDI

Identifiers

Primary DI / UDI-DI: 00197157005023 FDA UDI
510(k) Number: K141419 FDA UDI
FDA Product Code: NDN FDA UDI
HRX FDA UDI
GAA FDA UDI
GMDN Term: Balloon kyphoplasty kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
888.1100 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Balloon kyphoplasty kit

Zavation by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Balloon kyphoplasty kit.

TRACKER — GS Medical Co., Ltd. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
InflateFX™ Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC. · Class II
KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
MEDINAUT-I(ICD System) — IMEDICOM CO., LTD. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class I

Cleared under the same submission

K141419 also covers:

ZAVATION ZVplasty Balloon Catheter — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION
Zavation — ZAVATION

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zavation

Sources (1)

FDA UDI b4b3b902-0fc1-402e-a618-cf29224cb6a0 35 fields · synced May 30, 2026