The Gecko Spinal System— 510(k) K200281

Name: FDA 510(k) clearance K200281
Creator: U.S. Food and Drug Administration
Published: 2020-03-31

Substantially Equivalent

Ortho Development Corporation

FDA 510(k) clearance K200281 for The Gecko Spinal System, Substantially Equivalent on 2020-03-31. Applicant: Ortho Development Corporation. Device class: 2.

Clearance details

Applicant: Ortho Development Corporation
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2020-02-04
Decision date: 2020-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

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