Identity
- Trade Name
- Arcadia™ FDA UDI
- Generic Name
- Inflatable bone tamp FDA UDI
- Model / Reference
- 00884450447192 FDA UDI
Identifiers
- Catalog Number
- ARC15ST FDA UDI
- Primary DI / UDI-DI
- 00884450447192 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inflatable bone tamp
A comprehensive medical device for the reduction of fractures and creation of a void in cancellous bone, commonly used for kyphoplasty. It is an inflatable balloon-like catheter with an orthopaedic bone cement introduction into the created void to stabilize the vertebra.
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 ce8c6130-91ef-4b76-98c2-c690309cdbb0 34 fields · synced Jul 10, 2026