- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 1, 2025
081005552iFuseInstSetMLFixed Tracker Instrument Set is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SI-BONE, Inc.. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00855369008903400389(01)00855369008903
European Medical Device Nomenclature — the EU product classification assigned to this device.
L80SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIESUS-PR-000044785The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.081005552iFuseInstSetMLOn the market7.5mm/10.75mm iFuse Implant System Instrument Set (no disposables)081005552iFuseInstSetMLOn the marketiFuse TORQ Instrument Set081005552iFuseInstSetMLOn the marketiFuse TORQ Instrument Set, Fluoro081005552iFuseInstSetMLOn the marketiFuse TORQ Instrument Set, FT081005552iFuseInstSetMLOn the market