Minuteman G3

GUDID M9431000040160

MIS Fusion Plate

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant
Primary Device IDM9431000040160
NIH Device Record Key6ab9ab64-7955-4cd0-9309-c8983f3e6119
Commercial Distribution StatusIn Commercial Distribution
Brand NameMinuteman G3
Version Model Number10-0004-016
Company DUNS963359513
Company NameSPINAL SIMPLICITY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone913-451-4414
Emailinformation@spinalsimplicity.c
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com
Phone913-451-4414
Emailinformation@spinalsimplicity.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9431000040160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous Process Plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2015-10-23

On-Brand Devices [Minuteman G3]

M9431000040160MIS Fusion Plate
M9431000040140MIS Fusion Plate
M9431000040120MIS Fusion Plate
M9431000040100MIS Fusion Plate
M9431000040080MIS Fusion Plate

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