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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 / September 2026 / K262726

510(k) cleared

NeckTune SA Cervical Cage

Medyssey Co., Ltd. · Sep 29, 2026 · K262726

FDA cleared the NeckTune SA Cervical Cage from Medyssey Co., Ltd. on Sep 29, 2026 under K262726, 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 Jul 31, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Medyssey Co., Ltd. has one other decision in the tracker over the last 12 months: K260036 (NeckTune 3D SA Cervical Cage).

Questions & Answers

What did FDA clear under K262726?

K262726 is the FDA 510(k) for NeckTune SA Cervical Cage, submitted by Medyssey Co., Ltd.. FDA's decision date was Sep 29, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the NeckTune SA Cervical Cage?

Medyssey Co., Ltd., based in Jecheon-Si, is the applicant of record for K262726.

How long did the K262726 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Sep 29, 2026, 60 days later.

← All decisions in September 2026

Sources