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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 / December 2025 / K253200

510(k) cleared

Cervical Spine Truss System - Stand Alone (CSTS-SA)

4Web Medical, Inc. · Dec 11, 2025 · K253200

FDA cleared the Cervical Spine Truss System - Stand Alone (CSTS-SA) from 4Web Medical, Inc. on Dec 11, 2025 under K253200, a traditional 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

4Web Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K253201 (Lumbar Spine Truss System - Plating Solution (LSTS-PS)), K252834 (Sacroiliac Joint Truss System (SJTS)).

Questions & Answers

What did FDA clear under K253200?

K253200 is the FDA 510(k) for Cervical Spine Truss System - Stand Alone (CSTS-SA), submitted by 4Web Medical, Inc.. FDA's decision date was Dec 11, 2025, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the Cervical Spine Truss System - Stand Alone (CSTS-SA)?

4Web Medical, Inc., based in Frisco, TX, is the applicant of record for K253200.

How long did the K253200 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Dec 11, 2025, 76 days later.

← All decisions in December 2025

Sources