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 / February 2026 / K254105

510(k) cleared

Hive Standalone Cervical System and Hive C Interbody System

NanoHive Medical, LLC · Feb 13, 2026 · K254105

FDA cleared the Hive Standalone Cervical System and Hive C Interbody System from NanoHive Medical, LLC on Feb 13, 2026 under K254105, 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 Dec 19, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for NanoHive Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254105?

K254105 is the FDA 510(k) for Hive Standalone Cervical System and Hive C Interbody System, submitted by NanoHive Medical, LLC. FDA's decision date was Feb 13, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Hive Standalone Cervical System and Hive C Interbody System?

NanoHive Medical, LLC, based in Woburn, MA, is the applicant of record for K254105.

How long did the K254105 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Feb 13, 2026, 56 days later.

← All decisions in February 2026