ORTHOHUB EXTERNAL FIXATOR SOFTWARE— 510(k) K140550

Name: FDA 510(k) clearance K140550
Creator: U.S. Food and Drug Administration
Published: 2014-08-25

Substantially Equivalent

Orthohub, Inc.

FDA 510(k) clearance K140550 for ORTHOHUB EXTERNAL FIXATOR SOFTWARE, Substantially Equivalent on 2014-08-25. Applicant: Orthohub, Inc.. Device class: 2.

Clearance details

Applicant: Orthohub, Inc.
Product code: Code OSN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2014-03-04
Decision date: 2014-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSN

view all

K253764 — ENOS Software Guided External Fixation System2026-02-26
K221792 — Acute QC Strut and Components2022-08-25
K180539 — Deformity Analysis and Correction Software (DACS) and Instrumentation2018-08-13

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