Kalitec Direct InSePtion MIS Fixation System— 510(k) K163471

Name: FDA 510(k) clearance K163471
Creator: U.S. Food and Drug Administration
Published: 2017-03-16

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K163471 for Kalitec Direct InSePtion MIS Fixation System, Substantially Equivalent on 2017-03-16. Applicant: Kalitec Direct, LLC. Device class: 2.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-12-12
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.