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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262067

510(k) cleared

iFuse Granite Onyx Implant System

SI-BONE, Inc. · Sep 23, 2026 · K262067

FDA cleared the iFuse Granite Onyx Implant System from SI-BONE, Inc. on Sep 23, 2026 under K262067, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 22, 2026. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SI-BONE, Inc. has 2 other decisions in the tracker over the last 12 months: K253488 (iFuse INTRA Ti Implant System), K253094 (iFuse Bedrock Granite Implant System).

Questions & Answers

What did FDA clear under K262067?

K262067 is the FDA 510(k) for iFuse Granite Onyx Implant System, submitted by SI-BONE, Inc.. FDA's decision date was Sep 23, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the iFuse Granite Onyx Implant System?

SI-BONE, Inc., based in Santa Clara, CA, is the applicant of record for K262067.

How long did the K262067 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Sep 23, 2026, 93 days later.

← All decisions in September 2026

Sources