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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 / K263049

510(k) cleared

SABER-C System

Elevation Spine · Sep 23, 2026 · K263049

FDA cleared the SABER-C System from Elevation Spine on Sep 23, 2026 under K263049, a special 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 31, 2026. The decision came 23 days later, inside the 90 FDA-day goal for a 510(k).

Elevation Spine has 2 other decisions in the tracker over the last 12 months: K261408 (SABER-XA System), K260660 (SABER-C System).

Questions & Answers

What did FDA clear under K263049?

K263049 is the FDA 510(k) for SABER-C System, submitted by Elevation Spine. FDA's decision date was Sep 23, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the SABER-C System?

Elevation Spine, based in Monteray, CA, is the applicant of record for K263049.

How long did the K263049 review take?

FDA received the submission on Aug 31, 2026 and issued its decision on Sep 23, 2026, 23 days later.

← All decisions in September 2026

Sources