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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 / May 2026 / K261159

510(k) cleared

Exceed® Biplanar Expandable Interbody System

Spine Wave, Inc. · May 29, 2026 · K261159

FDA cleared the Exceed® Biplanar Expandable Interbody System from Spine Wave, Inc. on May 29, 2026 under K261159, a traditional 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 Apr 8, 2026. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

Spine Wave, Inc. has one other decision in the tracker over the last 12 months: K260286 (Dynamo Spinal Cement; Salvo® Spine System).

Questions & Answers

What did FDA clear under K261159?

K261159 is the FDA 510(k) for Exceed® Biplanar Expandable Interbody System, submitted by Spine Wave, Inc.. FDA's decision date was May 29, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Exceed® Biplanar Expandable Interbody System?

Spine Wave, Inc., based in Shelton, CT, is the applicant of record for K261159.

How long did the K261159 review take?

FDA received the submission on Apr 8, 2026 and issued its decision on May 29, 2026, 51 days later.

← All decisions in May 2026

Sources