HA Minuteman G3

GUDID M9431000170080

MIS Fusion Plate with HA coating

Spinal Simplicity, LLC

Interspinous spinal fixation implant
Primary Device IDM9431000170080
NIH Device Record Key6f9149f1-332f-417b-b516-3e24e8dbd00e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA Minuteman G3
Version Model Number10-0017-008
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
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com
Phone913-451-4414
Emailinfo@spinalsimplicity.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9431000170080 [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 Number6
Public Version Date2024-08-26
Device Publish Date2017-02-15

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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