Minuteman G5

GUDID M943100103000

Minuteman G5 MIS Fusion Plate

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant

• Primary Device ID: M943100103000
• NIH Device Record Key: 179633a3-5d2b-402a-8839-f4fbf2725b4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minuteman G5
• Version Model Number: 10-0103-000
• Company DUNS: 963359513
• Company Name: SPINAL SIMPLICITY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	M943100103000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211880

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: 2022-05-23
• Device Publish Date: 2022-05-13

On-Brand Devices [Minuteman G5]

• M943100104000: Minuteman G5 MIS Fusion Plate
• M943100103000: Minuteman G5 MIS Fusion Plate
• M943100102000: Minuteman G5 MIS Fusion Plate
• M943100101000: Minuteman G5 MIS Fusion Plate
• M943100100000: Minuteman G5 MIS Fusion Plate
• M9431001030000: Minuteman G5 MIS Fusion Plate
• M9431001020000: Minuteman G5 MIS Fusion Plate
• M9431001010000: Minuteman G5 MIS Fusion Plate
• M9431001000000: Minuteman G5 MIS Fusion Plate