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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Minuteman G6 MIS Fusion Plate; 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; Patriot SI Implant System; Liberty SI Lateral Implant System

FDA 510(k) source

510(k) number
K261607
Applicant
Spinal Simplicity, LLC
Decision date
Oct 2, 2026
Date received
May 14, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
PEK
Device type
Spinous Process Plate
Device class
Class II
Regulation
21 CFR 888.3050
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Overland Park, KS, US