HA Minuteman G3-R MIS Fusion Plate— 510(k) K163428

Name: FDA 510(k) clearance K163428
Creator: U.S. Food and Drug Administration
Published: 2017-02-02

Substantially Equivalent

Spinal Simplicity

FDA 510(k) clearance K163428 for HA Minuteman G3-R MIS Fusion Plate, Substantially Equivalent on 2017-02-02. Applicant: Spinal Simplicity. Device class: 2.

Clearance details

Applicant: Spinal Simplicity
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-12-06
Decision date: 2017-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

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