Minuteman G5 MIS Fusion Plate +3 more— 510(k) K233527

Name: FDA 510(k) clearance K233527
Creator: U.S. Food and Drug Administration
Published: 2023-11-29

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K233527 for Minuteman G5 MIS Fusion Plate +3 more, Substantially Equivalent on 2023-11-29. Applicant: Spinal Simplicity, LLC. Device class: 2.

Clearance details

Device name as filed: Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
Applicant: Spinal Simplicity, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2023-11-01
Decision date: 2023-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Overland Park, KS, 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.