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iFuse TORQ Instrument Set, Revision

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 400289

by SI-BONE, Inc.

Identity

Trade Name
iFuse TORQ Instrument Set, Revision EUDAMED
iFuse TORQ Implant System-iFuse-TORQ Instrument Set, Revision FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Device Name
Surgical Instrument Sets EUDAMED
iFuse-TORQ Instrument Set, Revision FDA UDI
Model / Reference
400289 EUDAMEDFDA UDI
Description
iFuse-TORQ Instrument Set, Revision FDA UDI

Identifiers

Primary DI / UDI-DI
00810055520015 EUDAMEDFDA UDI
Basic UDI-DI
081005552iFuseInstSetML EUDAMED
510(k) Number
K203247 FDA UDI
FDA Product Code
OUR 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 EUDAMED
Class II FDA UDI
Regulation Number
888.3040 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
MRI Safety
MR Conditional FDA UDI

iFuse TORQ Instrument Set, Revision 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 f2b39841-23e5-4db1-8e4e-b7ef62724a30 61 fields · synced Jul 28, 2026
  • FDA UDI 44c81446-b2a1-42f3-9533-741e529458bb 35 fields · synced May 29, 2026