Osteo3 ZP Putty— 510(k) K193075
Substantially EquivalentSirakoss , Ltd.
FDA 510(k) clearance K193075 for Osteo3 ZP Putty, Substantially Equivalent on 2020-06-09. Applicant: Sirakoss , Ltd.. Device class: 2.
Clearance details
- Applicant
- Sirakoss , 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
- Aberdeen, GB
Recent devices under product code MQV
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- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
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.