PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM— 510(k) K113218

Name: FDA 510(k) clearance K113218
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K113218 for PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2011-11-01
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, 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.