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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 / K260036

510(k) cleared

NeckTune 3D SA Cervical Cage

Medyssey Co, Ltd. · Jun 15, 2026 · K260036

FDA cleared the NeckTune 3D SA Cervical Cage from Medyssey Co, Ltd. on Jun 15, 2026 under K260036, a traditional 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 Jan 6, 2026. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medyssey Co, Ltd. has one other decision in the tracker over the last 12 months: K262726 (NeckTune SA Cervical Cage).

Questions & Answers

What did FDA clear under K260036?

K260036 is the FDA 510(k) for NeckTune 3D SA Cervical Cage, submitted by Medyssey Co, Ltd.. FDA's decision date was Jun 15, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the NeckTune 3D SA Cervical Cage?

Medyssey Co, Ltd., based in Jecheon-Si, is the applicant of record for K260036.

How long did the K260036 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Jun 15, 2026, 160 days later.

← All decisions in June 2026

Sources