HA Minuteman G3

GUDID M9431000170100

MIS Fusion Plate with HA coating

Spinal Simplicity, LLC

Interspinous spinal fixation implant

• Primary Device ID: M9431000170100
• NIH Device Record Key: b82d9a26-0bae-4e33-b016-7486a2131cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HA Minuteman G3
• Version Model Number: 10-0017-010
• 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: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com
• Phone: 913-451-4414
• Email: information@spinalsimplicity.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9431000170100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151741

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: 6
• Public Version Date: 2024-08-26
• Device Publish Date: 2016-03-30

On-Brand Devices [HA Minuteman G3]

• M94310001701609: MIS Fusion Plate with HA coating
• M94310001701407: MIS Fusion Plate with HA coating
• M94310001701205: 10-0017-012
• M94310001701003: 10-0017-010
• M9431000170080A: MIS Fusion Plate with HA coating
• M9431000170140: MIS Fusion Plate with HA coating
• M9431000170120: MIS Fusion Plate with HA coating
• M9431000170100: MIS Fusion Plate with HA coating
• M9431000170080: MIS Fusion Plate with HA coating