3DP Lumbar Interbody System GP3D-1128

GUDID M719GP3D11280

11mm x 28mm Parallel 3DP TPLIF

Genesys Orthopedics Systems LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M719GP3D11280
• NIH Device Record Key: 8a9fd4ed-e928-49ad-9ef9-d996c5df0983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DP Lumbar Interbody System
• Version Model Number: 1
• Catalog Number: GP3D-1128
• 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: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Dimensions

• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GP3D11280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220096

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

[M719GP3D11280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [3DP Lumbar Interbody System]

• M719GL3DS1840P0: Small Parallel LLIF - 18mm x 40mm
• M719GL3DS1835P0: Small Parallel LLIF - 18mm x 35mm
• M719GL3DS1830P0: Small Parallel LLIF - 18mm x 30mm
• M719GL3DS1825P0: Small Parallel LLIF - 18mm x 25mm
• M719GL3DS1660P0: Small Parallel LLIF - 16mm x 60mm
• M719GL3DS1655P0: Small Parallel LLIF - 16mm x 55mm
• M719GL3DS1650P0: Small Parallel LLIF - 16mm x 50mm
• M719GL3DS1645P0: Small Parallel LLIF - 16mm x 45mm
• M719GL3DS1640P0: Small Parallel LLIF - 16mm x 40mm
• M719GL3DS1635P0: Small Parallel LLIF - 16mm x 35mm
• M719GL3DS1630P0: Small Parallel LLIF - 16mm x 30mm
• M719GL3DS1625P0: Small Parallel LLIF - 16mm x 25mm
• M719GL3DS1460P0: Small Parallel LLIF - 14mm x 60mm
• M719GL3DS1455P0: Small Parallel LLIF - 14mm x 55mm
• M719GL3DS1450P0: Small Parallel LLIF - 14mm x 50mm
• M719GL3DS1445P0: Small Parallel LLIF - 14mm x 45mm
• M719GL3DS1440P0: Small Parallel LLIF - 14mm x 40mm
• M719GL3DS1435P0: Small Parallel LLIF - 14mm x 35mm
• M719GL3DS1430P0: Small Parallel LLIF - 14mm x 30mm
• M719GL3DS1425P0: Small Parallel LLIF - 14mm x 25mm
• M719GL3DS1260P0: Small Parallel LLIF - 12mm x 60mm
• M719GL3DS1255P0: Small Parallel LLIF - 12mm x 55mm
• M719GL3DS1250P0: Small Parallel LLIF - 12mm x 50mm
• M719GL3DS1245P0: Small Parallel LLIF - 12mm x 45mm
• M719GL3DS1240P0: Small Parallel LLIF - 12mm x 40mm
• M719GL3DS1235P0: Small Parallel LLIF - 12mm x 35mm
• M719GL3DS1230P0: Small Parallel LLIF - 12mm x 30mm
• M719GL3DS1225P0: Small Parallel LLIF - 12mm x 25mm
• M719GL3DS1060P0: Small Parallel LLIF - 10mm x 60mm
• M719GL3DS1055P0: Small Parallel LLIF - 10mm x 55mm
• M719GL3DS1050P0: Small Parallel LLIF - 10mm x 50mm
• M719GL3DS1045P0: Small Parallel LLIF - 10mm x 45mm
• M719GL3DS1040P0: Small Parallel LLIF - 10mm x 40mm
• M719GL3DS1035P0: Small Parallel LLIF - 10mm x 35mm
• M719GL3DS1030P0: Small Parallel LLIF - 10mm x 30mm
• M719GL3DS1025P0: Small Parallel LLIF - 10mm x 25mm
• M719GHA3D2030S0: Small Hyperlordotic 3DP ALIF 20mm x 30 degree
• M719GHA3D2030M0: Medium Hyperlordotic 3DP ALIF 20mm x 30 degree
• M719GHA3D2030L0: Large Hyperlordotic 3DP ALIF 20mm x 30 degree
• M719GHA3D2024S0: Small Hyperlordotic 3DP ALIF 20mm x 24 degree
• M719GHA3D2024M0: Medium Hyperlordotic 3DP ALIF 20mm x 24 degree
• M719GHA3D2024L0: Large Hyperlordotic 3DP ALIF 20mm x 24 degree
• M719GHA3D2018S0: Small Hyperlordotic 3DP ALIF 20mm x 18 degree
• M719GHA3D2018M0: Medium Hyperlordotic 3DP ALIF 20mm x 18 degree
• M719GHA3D2018L0: Large Hyperlordotic 3DP ALIF 20mm x 18 degree
• M719GHA3D1830S0: Small Hyperlordotic 3DP ALIF 18mm x 30 degree
• M719GHA3D1830M0: Medium Hyperlordotic 3DP ALIF 18mm x 30 degree
• M719GHA3D1824S0: Small Hyperlordotic 3DP ALIF 18mm x 24 degree
• M719GHA3D1824M0: Medium Hyperlordotic 3DP ALIF 18mm x 24 degree
• M719GHA3D1824L0: Large Hyperlordotic 3DP ALIF 18mm x 24 degree