JAZBI Resorbable Bone Void Filler— 510(k) K252797
Substantially EquivalentSdip 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.. Device class: 2.
Summary
Sdip Innovations filed the JAZBI Resorbable Bone Void Filler under MQV, calcium compound bone void fillers.
Class II, 21 CFR 888.3045. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Sdip filed from Hornsby, Australia. The decision came 265 calendar days after receipt (September 3, 2025 to May 26, 2026).
Clearance details
- Applicant
- Sdip Innovations Pty, Ltd.
- Product code
- Product code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hornsby, AU
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Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . 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.