HA Minuteman G1

GUDID M943100005016

MIS Fusion Plate with HA Coating

Spinal Simplicity, LLC

Interspinous spinal fixation implant

• Primary Device ID: M943100005016
• NIH Device Record Key: fd366acc-97a4-4463-a7cd-2ddb69dc40e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HA Minuteman G1
• Version Model Number: 10-0005-016
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M943100005016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200066

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: 2
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-03-07

On-Brand Devices [HA Minuteman G1]

• M943100005014: MIS Fusion Plate with HA Coating
• M943100005012: MIS Fusion Plate with HA Coating
• M943100005010: MIS Fusion Plate with HA Coating
• M943100005008: MIS Fusion Plate with HA Coating
• M943100005016: MIS Fusion Plate with HA Coating
• M9431000050160: MIS Fusion Plate with HA Coating
• M9431000050140: MIS Fusion Plate with HA Coating
• M9431000050120: MIS Fusion Plate with HA Coating
• M9431000050100: MIS Fusion Plate with HA Coating
• M9431000050080: MIS Fusion Plate with HA Coating