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SALTI 3.5mm Medial Distal Tibia Plate, 14 Hole, Left
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref B-251210Model SALTI
Identity
- Trade Name
- SALTI 3.5mm Medial Distal Tibia Plate, 14 Hole, Left EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- SALTI EUDAMEDB-251210 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187462449 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746SALTIHX EUDAMED
- Direct Marketing DI
- 07640187462449 EUDAMED
- 510(k) Number
- K242399 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMEDP09120599 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
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
SALTI 3.5mm Medial Distal Tibia Plate, 14 Hole, 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 | 764018746SALTIHX | 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 (3)
- EUDAMED 01322a1e-370f-4eca-ba14-8cce2d9b9436 61 fields · synced Jul 25, 2026
- FDA UDI 6a69f29a-bc79-4270-840e-f819e2b1a6d3 33 fields · synced May 29, 2026
- EUDAMED 67ebb356-e198-4538-b315-8bbbbe0f2854 61 fields · synced Jul 25, 2026