SALGINA 2.5mm Volar Distal Radius Plate, Narrow, Right
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- SALGINA 2.5mm Volar Distal Radius Plate, Narrow, Right EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- SALGINA EUDAMED
- Model / Reference
- SALGINA 2.5mm Distal Radius Plate EUDAMEDB-112000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187460001 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746SALGINAT3 EUDAMED
- Direct Marketing DI
- 07640187460001 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
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
SALGINA 2.5mm Volar Distal Radius Plate, Narrow, Right by Bonebridge AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018746SALGINAT3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (2)
- EUDAMED 4c040524-848a-47e3-87df-3918e08ab8ea 61 fields · synced Jun 18, 2026
- FDA UDI 34f1bb8c-1f00-4fb5-bcd4-0648f6941a02 33 fields · synced May 30, 2026