PILOT:GEN A,LEFT

GUDID 00815212023514

Izi Medical Products, LLC

Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant Vertebral body cement-containing implant

• Primary Device ID: 00815212023514
• NIH Device Record Key: a79b1bb4-e542-4cf9-86cd-26844d1fc8be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILOT:GEN A,LEFT
• Version Model Number: PLT2200
• Company DUNS: 933506164
• Company Name: Izi Medical Products, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212023514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141141

FDA Product Code

• LOD: Bone Cement

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: 2021-10-25
• Device Publish Date: 2021-10-15

Devices Manufactured by Izi Medical Products, LLC

• 00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D: 2024-03-26
• 00815212026812 - ONPOINT NAVIGATION KIT: 2024-03-06
• 00815212026829 - ONPOINT NAVIGATION TRAY: 2024-03-06
• 00815212026836 - ONPOINT SNAP SPHERZ 25PK: 2024-03-06
• 00815212026843 - ONPOINT SPHERZ PASSIVE MARKER-12 PACK: 2024-03-06
• 00815212026850 - ONPOINT PEDICLE ACCESS NEEDLE: 2024-03-06
• 10815212026819 - ONPOINT NAVIGATION 10 BOX: 2024-03-06
• 20815212026816 - ONPOINT NAVIGATION 25 BOXES: 2024-03-06