ZIP MIS INTERSPINOUS FUSION SYSTEM— 510(k) K140715

Name: FDA 510(k) clearance K140715
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Substantially Equivalent

Aurora Spine, Inc.

FDA 510(k) clearance K140715 for ZIP MIS INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2014-04-17. Applicant: Aurora Spine, Inc.. Device class: 2.

Clearance details

Applicant: Aurora Spine, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-03-21
Decision date: 2014-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, 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.