2.5 TriLock Wrist Fusion Plate Long Bend
EUDAMEDFDA UDIClass IIb (EU MDR)
by Medartis AG
Identity
- Trade Name
- 2.5 TriLock Wrist Fusion Plate Long Bend EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.5TriLock Total Wrist Fus.Pl Short Bend FDA UDI
- Model / Reference
- A-4760.07S EUDAMEDA-4760.06S FDA UDI
- Description
- 2.5TriLock Total Wrist Fus.Pl Short Bend FDA UDI
Identifiers
- Catalog Number
- A-4760.06S FDA UDI
- Primary DI / UDI-DI
- 07630037890867 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K232144 FDA UDI
- FDA Product Code
- HTY FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Germany 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
No
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
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable
2.5 TriLock Wrist Fusion Plate Long Bend by Medartis AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300378020P6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (2)
- EUDAMED 4c03b4a4-d7af-4922-a3c8-b49adb488a34 61 fields · synced Jun 17, 2026
- FDA UDI 3e14bc4a-20a7-49f8-a550-ce8df4b8852d 35 fields · synced May 30, 2026