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FDA 510(k)

JAZBI™ Resorbable Bone Void Filler

K-Number: K252797 · 2026-05-26

Decision Date2026-05-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZBI™ Resorbable Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Sdip Innovations Pty, Ltd.. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K252797. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZBI™ Resorbable Bone Void Filler?

JAZBI™ Resorbable Bone Void Filler is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Sdip Innovations Pty, Ltd.. The 510(k) number is K252797.

When did JAZBI™ Resorbable Bone Void Filler receive FDA 510(k) clearance?

JAZBI™ Resorbable Bone Void Filler received FDA 510(k) clearance on 2026-05-26, under 510(k) number K252797.

Who is the listed applicant for JAZBI™ Resorbable Bone Void Filler?

The FDA 510(k) record lists Sdip Innovations Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZBI™ Resorbable Bone Void Filler?

The FDA product code for JAZBI™ Resorbable Bone Void Filler is MQV.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.