510(k) K221545 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
MectaLIF Anterior Extension
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Oct 24, 2022 |
| Received | May 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device Completed |
OVD | None listed |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device Completed |
OVD | None listed |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device Completed |
OVD | None listed |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device Completed |
OVD | None listed |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device Completed |
OVD | None listed |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device Completed |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.