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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 / K253080

510(k) cleared

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

Suzhou and Science & Technology Development Corp. · Jun 18, 2026 · K253080

FDA cleared the AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) from Suzhou and Science & Technology Development Corp. on Jun 18, 2026 under K253080, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 23, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Suzhou and Science & Technology Development Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253080?

K253080 is the FDA 510(k) for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02), submitted by Suzhou and Science & Technology Development Corp.. FDA's decision date was Jun 18, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

Suzhou and Science & Technology Development Corp., based in Zhangjiagang, is the applicant of record for K253080.

How long did the K253080 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Jun 18, 2026, 268 days later.

← All decisions in June 2026