MectaLIF Anterior Extension— 510(k) K221545
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K221545 for MectaLIF Anterior Extension, Substantially Equivalent on 2022-10-24. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro (Ch), CH
Recent devices under product code OVD
view allMore clearances from Medacta International S.A.
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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 →
Recalls naming K221545
K-number listed on FDA's recall record- Z-1400-2023 — MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
- Z-1401-2023 — MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
- Z-1402-2023 — MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
- Z-1403-2023 — MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
- Z-1404-2023 — MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
- Z-1405-2023 — MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.