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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 / January 2026 / K254061

510(k) cleared

Curiteva Porous PEEK Cervical Interbody Fusion System

Curiteva, Inc. · Jan 15, 2026 · K254061

FDA cleared the Curiteva Porous PEEK Cervical Interbody Fusion System from Curiteva, Inc. on Jan 15, 2026 under K254061, 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 Dec 17, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Curiteva, Inc. has one other decision in the tracker over the last 12 months: K252205 (Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System).

Questions & Answers

What did FDA clear under K254061?

K254061 is the FDA 510(k) for Curiteva Porous PEEK Cervical Interbody Fusion System, submitted by Curiteva, Inc.. FDA's decision date was Jan 15, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Curiteva Porous PEEK Cervical Interbody Fusion System?

Curiteva, Inc., based in Tanner, AL, is the applicant of record for K254061.

How long did the K254061 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Jan 15, 2026, 29 days later.

← All decisions in January 2026

Sources