ZIP MIS INTERSPINOUS FUSION SYSTEM— 510(k) K133091

Name: FDA 510(k) clearance K133091
Creator: U.S. Food and Drug Administration
Published: 2013-11-27

Substantially Equivalent

Aurora Spine

FDA 510(k) clearance K133091 for ZIP MIS INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2013-11-27. Applicant: Aurora Spine. Device class: 2.

Clearance details

Applicant: Aurora Spine
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-09-30
Decision date: 2013-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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