MectaLIF Anterior Extension
FDA 510(k) clearance K221545 · decided 2022-10-24
Clearance details
- K-number
- K221545
- Device name
- MectaLIF Anterior Extension
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-27
- Decision date
- 2022-10-24
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro (Ch), CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device recall (Z-1400-2023) | Medacta Usa Inc | 2023-04-19 |
| MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device recall (Z-1401-2023) | Medacta Usa Inc | 2023-04-19 |
| MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device recall (Z-1402-2023) | Medacta Usa Inc | 2023-04-19 |
| MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device recall (Z-1403-2023) | Medacta Usa Inc | 2023-04-19 |
| MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device recall (Z-1404-2023) | Medacta Usa Inc | 2023-04-19 |
| MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device recall (Z-1405-2023) | Medacta Usa Inc | 2023-04-19 |