Vbb

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: VBB FDA UDI
Generic Name: Inflatable bone tamp FDA UDI
Device Name: VERTEBRAL BODY BALLOON/MEDIUM- STERILE FDA UDI
Model / Reference: 03.804.501S FDA UDI
Description: VERTEBRAL BODY BALLOON/MEDIUM- STERILE FDA UDI

Identifiers

Catalog Number: 03804501S FDA UDI
Primary DI / UDI-DI: 10705034722610 FDA UDI
510(k) Number: K110604 FDA UDI
FDA Product Code: HRX FDA UDI
NDN FDA UDI
GMDN Term: Inflatable bone tamp 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Inflatable bone tamp

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

Similar devices

Also classified as Inflatable bone tamp.

KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
SpineKure Kyphoplasty System — Hanchang Co., Ltd. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
KYPHON Xpander™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
KYPHON® Express™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Arcadia™ — Merit Medical Systems, Inc. · Class II
Arcadia™ — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K110604 also covers:

VBB — Synthes
VBB — Synthes

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: Synthes

Sources (1)

FDA UDI fdd67a11-f3d3-43cd-bea5-4f7f447bebd7 37 fields · synced May 31, 2026