7.5mm/10.75mm iFuse Implant System Instrument Set

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 400145510(k) K110838

by SI-BONE, Inc.

Identity

Trade Name: 7.5mm/10.75mm iFuse Implant System Instrument Set EUDAMED
7.5mm & 10.75mm Instrument Set FDA UDI
Generic Name: Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Device Name: Surgical Instrument Sets EUDAMED
7.5mm & 10.75mm Instrument Set FDA UDI
Model / Reference: 400145 EUDAMEDFDA UDI
Description: 7.5mm & 10.75mm Instrument Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00855369008989 EUDAMEDFDA UDI
Basic UDI-DI: 081005552iFuseInstSetML EUDAMED
FDA Product Code: OJH FDA UDI
EMDN Code: L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
GMDN Term: Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 878.4800 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

The 7.5mm/10.75mm iFuse Implant System Instrument Set is a collection of surgical instruments manufactured by SI-Bone, Inc. These instruments are specifically designed to facilitate the precise placement or removal of iFuse implants during orthopedic surgical procedures.

This set is supplied non-sterile and requires sterilization before use in a clinical setting. It is categorized as a Class I medical device and is identified by reference number 400145. The system is subject to regulatory oversight, including FDA 510(k) clearance and MDR compliance.

Frequently asked questions

Is the 7.5mm/10.75mm iFuse Implant System Instrument Set provided sterile?

No, the instrument set is supplied non-sterile. It must undergo an appropriate sterilization process before it can be used in a surgical environment.

What is the primary purpose of this instrument set?

The set is intended for use by surgeons to assist in the placement or removal of SI-BONE iFuse implants during orthopedic procedures.

What is the reference number for this specific instrument set?

The reference number for this 7.5mm/10.75mm iFuse Implant System Instrument Set is 400145.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K131405	Class I	Active
FDA 510(k)	United States	FDA_510K	K151718	Class I	Active
FDA 510(k)	United States	FDA_510K	K150875	Class I	Active
FDA 510(k)	United States	FDA_510K	K160652	Class I	Active
FDA 510(k)	United States	FDA_510K	K123850	Class I	Active
FDA 510(k)	United States	FDA_510K	K150714	Class I	Active
FDA 510(k)	United States	FDA_510K	K122074	Class I	Active
FDA 510(k)	United States	FDA_510K	K193524	Class I	Active
FDA 510(k)	United States	FDA_510K	K141049	Class I	Active
FDA 510(k)	United States	FDA_510K	K190230	Class I	Active
FDA 510(k)	United States	FDA_510K	K110838	Class I	Active
FDA 510(k)	United States	FDA_510K	K182983	Class I	Active
EUDAMED	European Union	CE/MDR	081005552iFuseInstSetML	Class I	Active

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Manufacturer

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

Sources (3)

EUDAMED a8b75603-ea9c-4d4f-a533-787cc9b1a9be 85 fields · synced Sep 18, 2026
FDA UDI 384db0ba-01f8-4fe4-8f87-1ee1acbe3d99 34 fields · synced May 30, 2026
FDA 510(k) K131405 1 fields · synced May 18, 2026