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Fixed Tracker Instrument Set

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 400389

by SI-BONE, Inc.

Identity

Trade Name
Fixed Tracker Instrument Set EUDAMED
iFuse Navigation Tracking System FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Surgical Instrument Sets EUDAMED
FIXED TRACKER SET FDA UDI
Model / Reference
400389 EUDAMEDFDA UDI
Description
FIXED TRACKER SET FDA UDI

Identifiers

Primary DI / UDI-DI
00855369008903 EUDAMEDFDA UDI
Basic UDI-DI
081005552iFuseInstSetML EUDAMED
510(k) Number
K232800 FDA UDI
FDA Product Code
HAW FDA UDI
EMDN Code
L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Medical Purpose
Surgical instrument sets for placing or removing SI-BONE implants EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Fixed Tracker Instrument Set by Si-Bone Inc. — Class I — 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

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Manufacturer

Manufacturer
SI-BONE, Inc.
EUDAMED SRN
US-PR-000044785

Sources (2)

  • EUDAMED 441eed2c-c135-48f7-b5a8-4b84c47408ad 61 fields · synced Jun 18, 2026
  • FDA UDI feda9739-cf7f-4362-80ea-6f1d53840a0d 35 fields · synced May 24, 2026