Idys LLIF 3DTi— 510(k) K202032

Name: FDA 510(k) clearance K202032
Creator: U.S. Food and Drug Administration
Published: 2021-04-01

Substantially Equivalent

Clariance, Sas

FDA 510(k) clearance K202032 for Idys LLIF 3DTi, Substantially Equivalent on 2021-04-01. Applicant: Clariance, Sas. Device class: 2.

Clearance details

Applicant: Clariance, Sas
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-07-22
Decision date: 2021-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

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K260810 — Anteralign LS coverplate2026-06-10

More clearances from Clariance, Sas

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K202956 — Erisma LP Navigated Instruments2021-02-26
K200920 — Idys ALIF ZP 3DTi2020-05-29
K192168 — Idys ALIF ZP 3DTi2019-11-04
K191263 — Idys ALIF TiVac2019-06-06
K183259 — Idys TLIF TiVac2019-03-01

Adverse events under product code OVD

product code OVD

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.