Formus Hip— 510(k) K213272

Substantially Equivalent

Formus Labs, Ltd.

FDA 510(k) clearance K213272 for Formus Hip, Substantially Equivalent on 2023-03-31. Applicant: Formus Labs, Ltd.. Device class: 2.

Clearance details

Applicant: Formus Labs, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-09-30
Decision date: 2023-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

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