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: 00884450490853 FDA UDI

Identifiers

Catalog Number: ARC15SB/A FDA UDI
Primary DI / UDI-DI: 00884450490853 FDA UDI
FDA Product Code: HRX FDA UDI
HXG 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
888.4540 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

Yes

FDA UDI

Category: Inflatable bone tamp

The Arcadia device is a versatile, single-use inflatable bone tamp used for the reduction of fractures and creation of voids in cancellous bone. This device has undergone comprehensive testing and regulatory approval to ensure its safety and efficacy for various orthopedic 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 1a74e974-5bb0-4fa0-9ad3-1dee3ed0ff5a 33 fields · synced Jul 12, 2026