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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 / K262149

510(k) cleared

corra® cervical plating system

Carlsmed, Inc. · Sep 24, 2026 · K262149 · In the directory

FDA cleared the corra® cervical plating system from Carlsmed, Inc. on Sep 24, 2026 under K262149, a traditional 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 25, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carlsmed, Inc. has 4 other decisions in the tracker over the last 12 months: K260385 (aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system), K260570 (corra cervical plating system), K252894 (aprevo® cervical interbody system), K252611 (aprevo® cervical plating system).

Questions & Answers

What did FDA clear under K262149?

K262149 is the FDA 510(k) for corra® cervical plating system, submitted by Carlsmed, Inc.. FDA's decision date was Sep 24, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the corra® cervical plating system?

Carlsmed, Inc., based in Carlsbad, CA, is the applicant of record for K262149. The company is listed in the MedDevice Startups directory.

How long did the K262149 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Sep 24, 2026, 91 days later.

← All decisions in September 2026