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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 / K263062

510(k) cleared

NOVIX Pedicle Screw System

Tdm Co., Ltd. · Oct 1, 2026 · K263062

FDA cleared the NOVIX Pedicle Screw System from Tdm Co., Ltd. on Oct 1, 2026 under K263062, a special 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 Sep 1, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Tdm Co., Ltd. has one other decision in the tracker over the last 12 months: K261611 (TDM Large Bone Plate and Screw System).

Questions & Answers

What did FDA clear under K263062?

K263062 is the FDA 510(k) for NOVIX Pedicle Screw System, submitted by Tdm Co., Ltd.. FDA's decision date was Oct 1, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the NOVIX Pedicle Screw System?

Tdm Co., Ltd., based in Gwangju, is the applicant of record for K263062.

How long did the K263062 review take?

FDA received the submission on Sep 1, 2026 and issued its decision on Oct 1, 2026, 30 days later.

← All decisions in October 2026

Sources