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POYA 3.5mm Posteromedial Tibia Plate, Left
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref B-221000Model POYA 3.5mm Lateral Proximal Tibia Plate
Identity
- Trade Name
- POYA 3.5mm Posteromedial Tibia Plate, 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-221000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461787 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746POYAKY EUDAMED
- Direct Marketing DI
- 07640187461787 EUDAMED
- 510(k) Number
- K213864 FDA UDI
- FDA Product Code
- HRS 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
MR Conditional FDA UDI
POYA 3.5mm Posteromedial Tibia Plate, Left by Bonebridge AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 dbdd0ee9-64d0-4255-9a2b-da29014e197f 61 fields · synced Jun 20, 2026
- FDA UDI bbe96772-d47e-411b-a50e-3fae88bb16c3 33 fields · synced May 30, 2026