HA Minuteman G3-R

GUDID M9431000220000

MIS Fusion Plate with HA coating

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device IDM9431000220000
NIH Device Record Keyfebbc880-b6cb-4c01-a496-01a2513a2017
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA Minuteman G3-R
Version Model Number10-0022-000
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

Phone9134514414
Emailinformation@spinalsimplicity.c
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com
Phone9134514414
Emailinformation@spinalsimplicity.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9431000220000 [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 Date2017-07-28

On-Brand Devices [HA Minuteman G3-R]

M9431000220000MIS Fusion Plate with HA coating
M9431000210000MIS Fusion Plate with HA coating
M9431000200000MIS Fusion Plate with HA coating
M9431000190000MIS Fusion Plate with HA coating
M9431000180000MIS Fusion Plate with HA coating

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