IMPLANT 3D— 510(k) K153091

Name: FDA 510(k) clearance K153091
Creator: U.S. Food and Drug Administration
Published: 2016-02-25

Substantially Equivalent

Media Lab S.R.L.

FDA 510(k) clearance K153091 for IMPLANT 3D, Substantially Equivalent on 2016-02-25. Applicant: Media Lab S.R.L.. Device class: 2.

Clearance details

Applicant: Media Lab S.R.L.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-10-26
Decision date: 2016-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Follo, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15
K261861 — SPINEsim v1.02026-09-15
K262060 — 3D-RD-S2026-09-04
K261500 — KBA3D (v2.4.0)2026-08-17

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.