HA Minuteman G3

GUDID M94310001701205

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant
Primary Device IDM94310001701205
NIH Device Record Key3663167b-ff0b-4724-9788-c0367338a4d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA Minuteman G3
Version Model Number10-0017-012
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
HIBCCM94310001701205 [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 Date2016-03-30

On-Brand Devices [HA Minuteman G3]

M94310001701609MIS Fusion Plate with HA coating
M94310001701407MIS Fusion Plate with HA coating
M9431000170120510-0017-012
M9431000170100310-0017-010
M9431000170080AMIS Fusion Plate with HA coating
M9431000170140MIS Fusion Plate with HA coating
M9431000170120MIS Fusion Plate with HA coating
M9431000170100MIS Fusion Plate with HA coating
M9431000170080MIS Fusion Plate with HA coating

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