Idys ALIF ZP 3DTi— 510(k) K200920

Clearance details

Applicant

Clariance, Sas

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2020-04-06

Decision date

2020-05-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Beaurains, FR

• 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

• K202032 — Idys LLIF 3DTi2021-04-01
• K202956 — Erisma LP Navigated Instruments2021-02-26
• K192168 — Idys ALIF ZP 3DTi2019-11-04
• K191263 — Idys ALIF TiVac2019-06-06
• K183259 — Idys TLIF TiVac2019-03-01

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 →