WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / K252240

510(k) cleared

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

Spectrum Spine · Mar 30, 2026 · K252240

FDA cleared the Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System from Spectrum Spine on Mar 30, 2026 under K252240, 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 Jul 17, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spectrum Spine has one other decision in the tracker over the last 12 months: K253377 (Expandable Titanium PLIF/TLIF System).

Questions & Answers

What did FDA clear under K252240?

K252240 is the FDA 510(k) for Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System, submitted by Spectrum Spine. FDA's decision date was Mar 30, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System?

Spectrum Spine, based in Jasper, GA, is the applicant of record for K252240.

How long did the K252240 review take?

FDA received the submission on Jul 17, 2025 and issued its decision on Mar 30, 2026, 256 days later.

← All decisions in March 2026

Sources