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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 / November 2025 / K252610

510(k) cleared

ZSFab Lumbar Interbody System

Zsfab, Inc. · Nov 25, 2025 · K252610

FDA cleared the ZSFab Lumbar Interbody System from Zsfab, Inc. on Nov 25, 2025 under K252610, a special 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 18, 2025. The decision came 99 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: K261451 (ZSAlign Cervical Interbody System), K260549 (ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System).

Questions & Answers

What did FDA clear under K252610?

K252610 is the FDA 510(k) for ZSFab Lumbar Interbody System, submitted by Zsfab, Inc.. FDA's decision date was Nov 25, 2025, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the ZSFab Lumbar Interbody System?

Zsfab, Inc., based in Waltham, MA, is the applicant of record for K252610.

How long did the K252610 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Nov 25, 2025, 99 days later.

← All decisions in November 2025

Sources