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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 / K262712

510(k) cleared

Duet Spinal Fixation System

Duet Spine Holdings, LLC · Sep 30, 2026 · K262712

FDA cleared the Duet Spinal Fixation System from Duet Spine Holdings, LLC on Sep 30, 2026 under K262712, a traditional 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 Jul 31, 2026. The decision came 61 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Duet Spine Holdings, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262712?

K262712 is the FDA 510(k) for Duet Spinal Fixation System, submitted by Duet Spine Holdings, LLC. FDA's decision date was Sep 30, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Duet Spinal Fixation System?

Duet Spine Holdings, LLC, based in Winona Lake, IN, is the applicant of record for K262712.

How long did the K262712 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Sep 30, 2026, 61 days later.

← All decisions in September 2026