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THE TAPE

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 / March 2026 / K252432

510(k) cleared

Flex-Z Cervical Cage

Spinepoint, LLC · Mar 25, 2026 · K252432

FDA cleared the Flex-Z Cervical Cage from Spinepoint, LLC on Mar 25, 2026 under K252432, a traditional 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 Aug 1, 2025. The decision came 236 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Spinepoint, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252432?

K252432 is the FDA 510(k) for Flex-Z Cervical Cage, submitted by Spinepoint, LLC. FDA's decision date was Mar 25, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Flex-Z Cervical Cage?

Spinepoint, LLC, based in Reno, NV, is the applicant of record for K252432.

How long did the K252432 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Mar 25, 2026, 236 days later.

← All decisions in March 2026