Release Laminoplasty Fixation System— 510(k) K153735

Name: FDA 510(k) clearance K153735
Creator: U.S. Food and Drug Administration
Published: 2016-01-21

Substantially Equivalent

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

FDA 510(k) clearance K153735 for Release Laminoplasty Fixation System, Substantially Equivalent on 2016-01-21. Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2015-12-28
Decision date: 2016-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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