Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate

Spinous Process Plate

Spinal Simplicity LLC

The following data is part of a premarket notification filed by Spinal Simplicity Llc with the FDA for Posterior Fusion Plate/ha Posterior Fusion Plate, Minuteman G3 Mis Fusion Plate, Ha Minuteman G3 Mis Fusion Plate, Ha Minuteman G3-r Mis Fusion Plate.

Pre-market Notification Details

Device IDK212781
510k NumberK212781
Device Name:Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
ClassificationSpinous Process Plate
Applicant Spinal Simplicity LLC 6600 College Blvd, Suite 220 Overland Park,  KS  66211
ContactAdam Rogers
CorrespondentAdam Rogers
Spinal Simplicity LLC 6600 College Blvd, Suite 220 Overland Park,  KS  66211
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-01
Decision Date2021-12-15

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