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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / June 2026 / K261209

510(k) cleared

Ion-L

SurGenTec, LLC · Jun 11, 2026 · K261209

FDA cleared the Ion-L from SurGenTec, LLC on Jun 11, 2026 under K261209, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 13, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

SurGenTec, LLC has 7 other decisions in the tracker over the last 12 months: K252995 (Durashield Device Kit), K262581 (GraftGun Universal Graft Delivery System (GDS®)), K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments).

Questions & Answers

What did FDA clear under K261209?

K261209 is the FDA 510(k) for Ion-L, submitted by SurGenTec, LLC. FDA's decision date was Jun 11, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the Ion-L?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K261209.

How long did the K261209 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jun 11, 2026, 59 days later.

← All decisions in June 2026