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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 / October 2026 / K263154

510(k) cleared

CarboClear® Cervical Navigated Instruments

CarboFix Orhtopedics , Ltd. · Oct 9, 2026 · K263154

FDA cleared the CarboClear® Cervical Navigated Instruments from CarboFix Orhtopedics , Ltd. on Oct 9, 2026 under K263154, a special 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 9, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for CarboFix Orhtopedics , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K263154?

K263154 is the FDA 510(k) for CarboClear® Cervical Navigated Instruments, submitted by CarboFix Orhtopedics , Ltd.. FDA's decision date was Oct 9, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the CarboClear® Cervical Navigated Instruments?

CarboFix Orhtopedics , Ltd., based in Herzeliya, is the applicant of record for K263154.

How long did the K263154 review take?

FDA received the submission on Sep 9, 2026 and issued its decision on Oct 9, 2026, 30 days later.

← All decisions in October 2026