Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System— 510(k) K241034
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K241034 for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System, Substantially Equivalent on 2024-06-12. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code PML
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- K222789 — VADER® Pedicle System, G21 Cement
More clearances from Medacta International S.A.
view allAdverse events under product code PML
product code PML- Death
- 8
- Total
- 8
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.