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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 / June 2026 / K260810

510(k) cleared

Anteralign LS coverplate

Tyber Medical, LLC · Jun 10, 2026 · K260810

FDA cleared the Anteralign LS coverplate from Tyber Medical, LLC on Jun 10, 2026 under K260810, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 12, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Tyber Medical, LLC has 5 other decisions in the tracker over the last 12 months: K261207 (Exalta Proximal Tibia Plating System), K261060 (Navigated LLIF Impactable Tracker), K253042 (Tyber Medical Trauma Screw), K252901 (Tyber Medical Trauma Screw).

Questions & Answers

What did FDA clear under K260810?

K260810 is the FDA 510(k) for Anteralign LS coverplate, submitted by Tyber Medical, LLC. FDA's decision date was Jun 10, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the Anteralign LS coverplate?

Tyber Medical, LLC, based in Bethlehem, PA, is the applicant of record for K260810.

How long did the K260810 review take?

FDA received the submission on Mar 12, 2026 and issued its decision on Jun 10, 2026, 90 days later.

← All decisions in June 2026

Sources