Affix IIS Spinous Process Plate System— 510(k) K143388

Name: FDA 510(k) clearance K143388
Creator: U.S. Food and Drug Administration
Published: 2015-03-05

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K143388 for Affix IIS Spinous Process Plate System, Substantially Equivalent on 2015-03-05. Applicant: Nu Vasive, Incorporated. Device class: 2.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-11-26
Decision date: 2015-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.