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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261451

510(k) cleared

ZSAlign Cervical Interbody System

ZSFab, Inc. · Jul 31, 2026 · K261451

FDA cleared the ZSAlign Cervical Interbody System from ZSFab, Inc. on Jul 31, 2026 under K261451, a traditional 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 May 1, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ZSFab, Inc. has 2 other decisions in the tracker over the last 12 months: K260549 (ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System), K252610 (ZSFab Lumbar Interbody System).

Questions & Answers

What did FDA clear under K261451?

K261451 is the FDA 510(k) for ZSAlign Cervical Interbody System, submitted by ZSFab, Inc.. FDA's decision date was Jul 31, 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 K261451.

How long did the K261451 review take?

FDA received the submission on May 1, 2026 and issued its decision on Jul 31, 2026, 91 days later.

← All decisions in July 2026

Sources