SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM— 510(k) K122822

Name: FDA 510(k) clearance K122822
Creator: U.S. Food and Drug Administration
Published: 2013-02-07

Substantially Equivalent

Spectrum Spine, LLC

FDA 510(k) clearance K122822 for SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM, Substantially Equivalent on 2013-02-07. Applicant: Spectrum Spine, LLC. Device class: 2.

Clearance details

Applicant: Spectrum Spine, LLC
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2012-09-14
Decision date: 2013-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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.