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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 / K263172

510(k) cleared

SAS MIS Pelvic Incidence Rods

Spinal Alignment Solutions, Inc. · Sep 30, 2026 · K263172

FDA cleared the SAS MIS Pelvic Incidence Rods from Spinal Alignment Solutions, Inc. on Sep 30, 2026 under K263172, a special 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 Sep 10, 2026. The decision came 20 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Spinal Alignment Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K263172?

K263172 is the FDA 510(k) for SAS MIS Pelvic Incidence Rods, submitted by Spinal Alignment Solutions, Inc.. FDA's decision date was Sep 30, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the SAS MIS Pelvic Incidence Rods?

Spinal Alignment Solutions, Inc., based in Wilmington, NC, is the applicant of record for K263172.

How long did the K263172 review take?

FDA received the submission on Sep 10, 2026 and issued its decision on Sep 30, 2026, 20 days later.

← All decisions in September 2026