Expedium
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EXPEDIUM SPINE SYSTEM EUDAMEDEXPEDIUM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Straight rod, Rod, Commercially Pure Rod, Commercially Pure Rod with Hex Ends, Dual Diameter Rod, Dual Diameter Straight Rod, etc. EUDAMEDEXPEDIUM SPINE SYSTEM PRE-CONTOURED ROD, SHORT diameter 4.5mm FDA UDI
- Model / Reference
- 186189380S EUDAMEDFDA UDIEXPEDIUM Spine System Rod EUDAMED
- Description
- EXPEDIUM SPINE SYSTEM PRE-CONTOURED ROD, SHORT diameter 4.5mm FDA UDI
Identifiers
- Catalog Number
- 186189380S FDA UDI
- Primary DI / UDI-DI
- 10705034562544 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0016667 EUDAMED
- 510(k) Number
- K200245 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIOSH FDA UDIKWQ FDA UDIMNH FDA UDIKWP FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Bone-screw internal spinal fixation system rod
Expedium by Medos International Sàrl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (2)
- FDA UDI 27e7ce72-dc53-4868-8676-03c7b0586167 36 fields · synced Jun 8, 2026
- EUDAMED f37e28be-1b76-483c-a051-111c4e2949e4 61 fields · synced Jun 8, 2026