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SALTI 3.5mm Posterior Distal Tibia Plate, 4 Hole
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref B-253000Model SALTI
Identity
- Trade Name
- SALTI 3.5mm Posterior Distal Tibia Plate, 4 Hole EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- SALTI EUDAMEDB-253000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187462463 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746SALTIHX EUDAMED
- Direct Marketing DI
- 07640187462463 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 Posterior Distal Tibia Plate, 4 Hole 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 c4e7f6c3-f99d-473f-9a1c-9bcc4c13d8fe 61 fields · synced Jun 19, 2026
- FDA UDI 85e805c6-f4eb-42f6-9414-66dc939924e3 33 fields · synced May 30, 2026
- EUDAMED 0de213cf-e436-43fb-bafe-4376c460d126 61 fields · synced Jun 19, 2026