3DP Lumbar Interbody GP3D-1128L4

GUDID M719GP3D1128L40

11mm x 28mm 4deg Lordotic 3DP TPLIF

Genesys Orthopedics Systems LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M719GP3D1128L40
• NIH Device Record Key: 73adb6ff-5b87-412f-b69e-38e4d7e6ef50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DP Lumbar Interbody
• Version Model Number: 1
• Catalog Number: GP3D-1128L4
• Company DUNS: 017921066
• Company Name: Genesys Orthopedics Systems 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GP3D1128L40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182987

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M719GP3D1128L40]

Moist Heat or Steam Sterilization

[M719GP3D1128L40]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-29
• Device Publish Date: 2025-08-21

On-Brand Devices [3DP Lumbar Interbody]

• M719GLL1050: Modular Hudson Connect T-Handle
• M719GLL1070: LLIF Angled Big Inserter
• M719GLL1060: LLIF Big Inserter
• M719GP3D1128L40: 11mm x 28mm 4deg Lordotic 3DP TPLIF