EasyWinch 20 mm

FDA UDI

Class II (US FDA UDI)

by G21 Srl

Identity

Trade Name: EasyWinch 20 mm FDA UDI
Generic Name: Balloon kyphoplasty kit FDA UDI
Model / Reference: 900199 FDA UDI

Identifiers

Primary DI / UDI-DI: 08058964727596 FDA UDI
510(k) Number: K172214 FDA UDI
FDA Product Code: HRX FDA UDI
NDN FDA UDI
GMDN Term: Balloon kyphoplasty kit FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Balloon kyphoplasty kit

EasyWinch 20 mm by G21 Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Balloon kyphoplasty kit.

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MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
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KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
Zavation — ZAVATION · Class II
SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II

Cleared under the same submission

K172214 also covers:

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: G21 Srl

Sources (1)

FDA UDI 6f2e0f51-aa52-4638-98a5-04875a2ecc83 33 fields · synced Jun 8, 2026