ORTELIUS 800— 510(k) K011827

Substantially Equivalent

Orthoscan , Ltd.

FDA 510(k) clearance K011827 for ORTELIUS 800, Substantially Equivalent on 2001-08-28. Applicant: Orthoscan , Ltd.. Device class: 1.

Clearance details

Applicant: Orthoscan , Ltd.
Product code: Code KQX
Device class: Class 1
Regulation: 21 CFR 888.1500
Advisory panel: Orthopedic
Date received: 2001-06-12
Decision date: 2001-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna, IL

Download summary PDF View on FDA.gov ↗

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