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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 / May 2026 / K252797

510(k) cleared

JAZBI Resorbable Bone Void Filler

Sdip Innovations Pty, Ltd. · May 26, 2026 · K252797

FDA cleared the JAZBI Resorbable Bone Void Filler from Sdip Innovations Pty, Ltd. on May 26, 2026 under K252797, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 3, 2025. The decision came 265 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 Sdip Innovations Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252797?

K252797 is the FDA 510(k) for JAZBI Resorbable Bone Void Filler, submitted by Sdip Innovations Pty, Ltd.. FDA's decision date was May 26, 2026, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the JAZBI Resorbable Bone Void Filler?

Sdip Innovations Pty, Ltd., based in Hornsby, is the applicant of record for K252797.

How long did the K252797 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on May 26, 2026, 265 days later.

← All decisions in May 2026