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Surgical Instrument Sets

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 400463

by SI-BONE, Inc.

Identity

Trade Name
iFuse TORQ TNT Instrument Set FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Device Name
Surgical Instrument Sets EUDAMED
iFuse TORQ TNT Instrument Set FDA UDI
Model / Reference
400463 EUDAMEDFDA UDI
Description
iFuse TORQ TNT Instrument Set FDA UDI

Identifiers

Primary DI / UDI-DI
00810055524433 EUDAMEDFDA UDI
Basic UDI-DI
081005552iFuseInstSetML EUDAMED
510(k) Number
K241504 FDA UDI
FDA Product Code
OLO FDA UDI
LXH FDA UDI
EMDN Code
L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
888.4540 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Surgical Instrument Sets 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 a19f5d4f-52fe-4a37-9661-4460f65b7231 61 fields · synced Jun 18, 2026
  • FDA UDI 5e8278a1-5ec8-40e8-970d-395646f3173f 35 fields · synced May 30, 2026