IMPIX ALIF S/A— 510(k) K141187

Clearance details

Applicant

Medicrea International SA

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2014-05-08

Decision date

2015-01-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Neyron, FR

• K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
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• K261809 — Interwedge® Standalone Lateral2026-07-31
• K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
• K260810 — Anteralign LS coverplate2026-06-10

• K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24
• K213281 — PASS LP Spinal System, CD Horizon Spinal System2022-01-05
• K210470 — C-CURVE Interbody Fusion Device2021-09-03
• K200316 — UNiD IB3D ALIF2020-10-30
• K191134 — IB3D ALIF2019-10-30

Death

5

Injury

495

Total

500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2454-2023 — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarClass II·Ongoing·Medicrea International·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141187.