Minuteman G5

GUDID M943100101000

Minuteman G5 MIS Fusion Plate

SPINAL SIMPLICITY, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant

• Primary Device ID: M943100101000
• NIH Device Record Key: 698590ee-6dc9-4c94-aed1-c378b8eac1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minuteman G5
• Version Model Number: 10-0101-000
• 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	M943100101000 [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