JAZBI Resorbable Bone Void Filler— 510(k) K252797

Substantially Equivalent

Sdip Innovations Pty, Ltd.

FDA 510(k) clearance K252797 for JAZBI Resorbable Bone Void Filler, Substantially Equivalent on 2026-05-26. Applicant: Sdip Innovations Pty, Ltd..

Clearance details

Applicant: Sdip Innovations Pty, Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2025-09-03
Decision date: 2026-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hornsby, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.