POYA 3.5mm Lateral Proximal Tibia Plate, 4 Hole, Left
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- POYA 3.5mm Lateral Proximal Tibia Plate, 4 Hole, Left EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- POYA EUDAMED
- Model / Reference
- POYA 3.5mm Lateral Proximal Tibia Plate EUDAMEDB-231100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461978 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746POYAKY EUDAMED
- Direct Marketing DI
- 07640187461978 EUDAMED
- 510(k) Number
- K231292 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC 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
- 888.3030 FDA UDI888.3040 FDA UDI
- 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
No
Category: Orthopaedic fixation plate, non-bioabsorbable
POYA 3.5mm Lateral Proximal Tibia Plate, 4 Hole, Left by Bonebridge 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 | 764018746POYAKY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (2)
- EUDAMED d80aba20-83b9-4b14-9799-5794ef667c7d 61 fields · synced Jul 9, 2026
- FDA UDI a287d136-6767-4fee-9b39-e60208746a02 33 fields · synced May 30, 2026