K233527

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

510(k) number
K233527
Device name
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 KS · US
Product code
PEK — Spinous Process Plate
Decision date
2023-11-29
Date received
2023-11-01
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K233527.pdf

Official FDA record: K233527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.