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SI-BONE, INC.

USA · Santa Clara

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 6Class II 5Class III 0

plus 70 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 3IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States70 registration records, 32 510(k), 0 PMA, 10 excluded

Brazil0 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: SI-BONE, INC. · SI-BONE INC.

Business registration

CIK: 0001459839
Registration status: Active
Listing status: Listed (SIBN)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12008

12009

12011

12012

22013

12014

32015

32016

22017

12018

12019

22020

12021

42022

12023

42024

22025

12026

FDA listed device types

showing 8 of 11

Thoracolumbosacral Pedicle Screw System 1Screw, Fixation, Bone 1Neurosurgical Nerve Locator 1Orthopedic Stereotaxic Instrument 1Sacroiliac Joint Fixation 1Bit, Drill 1Hammer, Surgical 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253488	iFuse INTRA Ti Implant System	2026-02-11
US	K253094	iFuse Bedrock Granite Implant System	2025-10-09
US	K251780	iGPS Navigation Instruments	2025-09-15
CA	95222	IFUSE IMPLANT SYSTEM	Class III

SI-BONE, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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