Minuteman G1

GUDID M943100001014

MIS Fusion Plate

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant

• Primary Device ID: M943100001014
• NIH Device Record Key: 8d8b58c6-a2fb-4a25-8876-b2d5bbb55316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minuteman G1
• Version Model Number: 10-0001-014
• 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	M943100001014 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-15
• Device Publish Date: 2022-03-07

On-Brand Devices [Minuteman G1]

• M943100001016: MIS Fusion Plate
• M943100001014: MIS Fusion Plate
• M943100001012: MIS Fusion Plate
• M943100001010: MIS Fusion Plate
• M943100001008: MIS Fusion Plate
• M9431000010140: MIS Fusion Plate
• M9431000010120: MIS Fusion Plate
• M9431000010100: MIS Fusion Plate
• M9431000010080: MIS Fusion Plate