Arcadia™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Arcadia™ FDA UDI
Generic Name: Inflatable bone tamp FDA UDI
Model / Reference: F FDA UDI

Identifiers

Catalog Number: ARC15ST-LK FDA UDI
Primary DI / UDI-DI: 00884450815496 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Inflatable bone tamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 10 Gauge FDA UDI
Balloon Length — 15 Millimeter FDA UDI

Category: Inflatable bone tamp

Explore the Arcadia device, a cutting-edge, in-office treatment solution for managing vertebral fractures and compression fractures. With its unique inflatable balloon technology and orthopaedic bone cement, this device offers unparalleled effectiveness and minimally invasive procedures.

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
Osseoflex SB Steerable Balloon (8ga/2ml) — Osseon, LLC · Class II
Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) — Osseon, LLC · Class II

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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 224eaad3-5644-4c89-a631-ce396bbee80e 34 fields · synced Jul 18, 2026