Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5— 510(k) K221023

Name: FDA 510(k) clearance K221023
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K221023 for Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5, Substantially Equivalent on 2022-08-19. Applicant: Spinal Simplicity, LLC. Device class: 2.

Clearance details

Applicant: Spinal Simplicity, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2022-04-06
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
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.