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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 / July 2026 / K254130

510(k) cleared

C.A. Medical Interbody Fusion System

C.A. Medical, LLC · Jul 8, 2026 · K254130

FDA cleared the C.A. Medical Interbody Fusion System from C.A. Medical, LLC on Jul 8, 2026 under K254130, a special 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 22, 2025. The decision came 198 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

C.A. Medical, LLC has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K254130?

K254130 is the FDA 510(k) for C.A. Medical Interbody Fusion System, submitted by C.A. Medical, LLC. FDA's decision date was Jul 8, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the C.A. Medical Interbody Fusion System?

C.A. Medical, LLC, based in Southlake, TX, is the applicant of record for K254130.

How long did the K254130 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Jul 8, 2026, 198 days later.

← All decisions in July 2026