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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 / K263159

510(k) cleared

prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments

Centinel Spine, LLC · Oct 7, 2026 · K263159

FDA cleared the prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments from Centinel Spine, LLC on Oct 7, 2026 under K263159, a special 510(k). The device falls under product code QLQ, Manual Instruments Designed For Use With Total Disc Replacement Devices, regulated at 21 CFR 888.4515 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 9, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K263159?

K263159 is the FDA 510(k) for prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments, submitted by Centinel Spine, LLC. FDA's decision date was Oct 7, 2026, under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices).

Who makes the prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments?

Centinel Spine, LLC, based in West Chester, PA, is the applicant of record for K263159.

How long did the K263159 review take?

FDA received the submission on Sep 9, 2026 and issued its decision on Oct 7, 2026, 28 days later.

← All decisions in October 2026