icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)— 510(k) K232792

Clearance details

Applicant

Icotec AG

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2023-09-11

Decision date

2024-04-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

9450 Altstaetten (Sg), CH

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K242900 — VADER® Pedicle System and VADER®one Pedicle System2025-02-27
• K233215 — icotec Anterior Cervical Plate System2024-05-17
• K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04
• K232628 — VADER® Pedicle System2024-02-26

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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 →