HA Minuteman G3-R

GUDID M9431000190000

MIS Fusion Plate with HA coating

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant

• Primary Device ID: M9431000190000
• NIH Device Record Key: fe71fd20-f0fc-4133-985f-3d5cf07052b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HA Minuteman G3-R
• Version Model Number: 10-0019-000
• Company DUNS: 963359513
• Company Name: SPINAL SIMPLICITY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9134514414
• Email: information@spinalsimplicity.c
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com
• Phone: 9134514414
• Email: information@spinalsimplicity.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9431000190000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163428

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-07-26

On-Brand Devices [HA Minuteman G3-R ]

• M9431000220000: MIS Fusion Plate with HA coating
• M9431000210000: MIS Fusion Plate with HA coating
• M9431000200000: MIS Fusion Plate with HA coating
• M9431000190000: MIS Fusion Plate with HA coating
• M9431000180000: MIS Fusion Plate with HA coating