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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 / October 2025 / K252737

510(k) cleared

DeGen Medical Latitude-C AM Cervical Interbody Fusion System

Degen Medical · Oct 10, 2025 · K252737

FDA cleared the DeGen Medical Latitude-C AM Cervical Interbody Fusion System from Degen Medical on Oct 10, 2025 under K252737, 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 28, 2025. The decision came 43 days later, inside the 90 FDA-day goal for a 510(k).

Degen Medical has one other decision in the tracker over the last 12 months: K251829 (DeGen Medical Patient Specific Implant (PSI) System).

Questions & Answers

What did FDA clear under K252737?

K252737 is the FDA 510(k) for DeGen Medical Latitude-C AM Cervical Interbody Fusion System, submitted by Degen Medical. FDA's decision date was Oct 10, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

Degen Medical, based in Florence, SC, is the applicant of record for K252737.

How long did the K252737 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Oct 10, 2025, 43 days later.

← All decisions in October 2025

Sources