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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 / April 2026 / K260549

510(k) cleared

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

Zsfab, Inc. · Apr 24, 2026 · K260549

FDA cleared the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System from Zsfab, Inc. on Apr 24, 2026 under K260549, 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 Feb 18, 2026. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).

Zsfab, Inc. has 2 other decisions in the tracker over the last 12 months: K261451 (ZSAlign Cervical Interbody System), K252610 (ZSFab Lumbar Interbody System).

Questions & Answers

What did FDA clear under K260549?

K260549 is the FDA 510(k) for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System, submitted by Zsfab, Inc.. FDA's decision date was Apr 24, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

Zsfab, Inc., based in Waltham, MA, is the applicant of record for K260549.

How long did the K260549 review take?

FDA received the submission on Feb 18, 2026 and issued its decision on Apr 24, 2026, 65 days later.

← All decisions in April 2026

Sources