FDA.reportPublic FDA data

510(k) K262067

Device
iFuse Granite Onyx™ Implant System
Applicant
SI-BONE, Inc.
510(k) number
K262067
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-23
Date received
2026-06-22
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jayasri Prabakaran
Address
471 El Camino Real Suite 101 Santa Clara CA US 95050 95050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.2026-10-02
K263062NOVIX Pedicle Screw SystemTdm Co., Ltd.2026-10-01
K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC2026-09-30
K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.2026-09-30
K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.2026-09-27
K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi2026-09-17
K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical2026-09-14
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-09-04
K253943Tiger 2 SystemZavation Medical Products, LLC2026-07-24
K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.2026-07-24
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.2026-07-14
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-07-01
K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.2026-06-17
K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.2026-06-09
K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)2026-05-15