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.
Clearance details
- Applicant
- Sdip Innovations Pty, Ltd.
- Product code
- 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.