SPINOUS PROCESS FUSION (SPF) PLATE— 510(k) K140046

Name: FDA 510(k) clearance K140046
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K140046 for SPINOUS PROCESS FUSION (SPF) PLATE, Substantially Equivalent on 2015-01-09. Applicant: Spinal Simplicity, LLC. Device class: 2.

Clearance details

Applicant: Spinal Simplicity, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-01-08
Decision date: 2015-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, 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.