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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 / K263113

510(k) cleared

ZSAlign Cervical Interbody System

ZSFab, Inc. · Oct 2, 2026 · K263113

FDA cleared the ZSAlign Cervical Interbody System from ZSFab, Inc. on Oct 2, 2026 under K263113, a special 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 Sep 4, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

ZSFab, Inc. has 3 other decisions in the tracker over the last 12 months: K261451 (ZSAlign Cervical Interbody System), K260549 (ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System), K252610 (ZSFab Lumbar Interbody System).

Questions & Answers

What did FDA clear under K263113?

K263113 is the FDA 510(k) for ZSAlign Cervical Interbody System, submitted by ZSFab, Inc.. FDA's decision date was Oct 2, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the ZSAlign Cervical Interbody System?

ZSFab, Inc., based in Waltham, MA, is the applicant of record for K263113.

How long did the K263113 review take?

FDA received the submission on Sep 4, 2026 and issued its decision on Oct 2, 2026, 28 days later.

← All decisions in October 2026

Sources