506105 Lumbar Interbody System GP3D-15C

GUDID M719GP3D15C0

15mm Convex 3DP PLIF

Genesys Orthopedics Systems LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M719GP3D15C0
• NIH Device Record Key: 600f45af-147d-41ee-a1c4-1aadd5515305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 506105 Lumbar Interbody System
• Version Model Number: 1
• Catalog Number: GP3D-15C
• 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: true
• 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
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GP3D15C0 [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

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

[M719GP3D15C0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-27
• Device Publish Date: 2025-08-19

Devices Manufactured by Genesys Orthopedics Systems LLC

• M719GSI247S000 - Sacroiliac Joint Fusion System: 2025-09-30 SI-O PL Drill Guide - 00 Degree Short
• M719GSI247S100 - Sacroiliac Joint Fusion System: 2025-09-30 SI-O PL Drill Guide - 10 Degree Short
• M719GSI247S200 - Sacroiliac Joint Fusion System: 2025-09-30 SI-O PL Drill Guide - 20 Degree Short
• M719GSI247S300 - Sacroiliac Joint Fusion System: 2025-09-30 SI-O PL Drill Guide - 30 Degree Short
• M719GSI247S400 - Sacroiliac Joint Fusion System: 2025-09-30 SI-O PL Drill Guide - 40 Degree Short
• M719GSISF095350 - Sacroiliac Joint Fusion System: 2025-09-30 9.5mm x 35mm SI Screw - Full Thread
• M719GSISF095400 - Sacroiliac Joint Fusion System: 2025-09-30 9.5mm x 40mm SI Screw - Full Thread
• M719GSISF095450 - Sacroiliac Joint Fusion System: 2025-09-30 9.5mm x 45mm SI Screw - Full Thread