SALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Right

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref B-252120Model SALTIRef B-251120

by Bonebridge AG

Identity

Trade Name: SALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Right EUDAMEDFDA UDI
SALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Left EUDAMEDFDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Model / Reference: SALTI EUDAMED
B-252120 EUDAMEDFDA UDI
B-251120 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 07640187462500 EUDAMEDFDA UDI
07640187462494 EUDAMEDFDA UDI
Basic UDI-DI: 764018746SALTIHX EUDAMED
Direct Marketing DI: 07640187462500 EUDAMED
07640187462494 EUDAMED
510(k) Number: K242399 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
EMDN Code: P09120599 BONE FIXATION PLATES - OTHER EUDAMED
P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 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

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

SALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Right by Bonebridge AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

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

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

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 (5)

EUDAMED a6d4b8bd-fafc-437d-9ccf-311116b6932b 61 fields · synced Oct 6, 2026
EUDAMED d1e3c408-4c8e-46e0-813d-bc3dd139f95a 61 fields · synced May 18, 2026
FDA UDI baa7b779-5f48-4b84-93ae-df0b3b8b6cd2 33 fields · synced May 30, 2026
FDA UDI 37e812ce-be9c-442a-b6b7-9543252b056b 33 fields · synced May 30, 2026
EUDAMED a6935d95-c659-4cca-abac-447d72862ab1 61 fields · synced Jul 13, 2026