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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 / K261279

510(k) cleared

DeltaNEC Interbody System

Nexus Spine · Jun 22, 2026 · K261279

FDA cleared the DeltaNEC Interbody System from Nexus Spine on Jun 22, 2026 under K261279, 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 Apr 17, 2026. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Nexus Spine in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261279?

K261279 is the FDA 510(k) for DeltaNEC Interbody System, submitted by Nexus Spine. FDA's decision date was Jun 22, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the DeltaNEC Interbody System?

Nexus Spine, based in Salt Lake City, UT, is the applicant of record for K261279.

How long did the K261279 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Jun 22, 2026, 66 days later.

← All decisions in June 2026