3DP Cervical Interbody System GC3-TH-L05-SD

GUDID M719GC3THL05SD0

Large 5mm 3DP Cervical Trial with Handle, No Stop - Short Depth

Genesys Orthopedics Systems LLC

Spinal implant trial

• Primary Device ID: M719GC3THL05SD0
• NIH Device Record Key: 1cba978f-1629-4342-8ec8-127d5e7f5e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DP Cervical Interbody System
• Version Model Number: 1
• Catalog Number: GC3-TH-L05-SD
• 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: false
• 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

Device Dimensions

• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GC3THL05SD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191489

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

[M719GC3THL05SD0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [3DP Cervical Interbody System]

• M719GCP3D12S0: 12mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D12L0: 12mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D11S0: 11mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D11L0: 11mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D10S0: 10mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D10L0: 10mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D09S0: 9mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D09L0: 9mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D08S0: 8mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D08L0: 8mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D07S0: 7mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D07L0: 7mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D06S0: 6mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D06L0: 6mm 3DP Cervical Interbody, Large, Parallel
• M719GCP3D05S0: 5mm 3DP Cervical Interbody, Small, Parallel
• M719GCP3D05L0: 5mm 3DP Cervical Interbody, Large, Parallel
• M719GCL3D12S0: 12mm 3DP Cervical Interbody, Small, Parallel
• M719GCL3D12L0: 12mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D11S0: 11mm 3DP Cervical Interbody, Small, Lordotic
• M719GCL3D11L0: 11mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D10S0: 10mm 3DP Cervical Interbody, Small, Lordotic
• M719GCL3D10L0: 10mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D09S0: 9mm 3DP Cervical Interbody, Small, Lordotic
• M719GCL3D09L0: 9mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D08S0: 8mm 3DP Cervical Interbody, Small, Lordotic
• M719GCL3D08L0: 8mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D07S0: 7mm Cervical Interbody, Small, Lordotic
• M719GCL3D07L0: 7mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D06S0: 6mm 3DP Cervical Interbody, Small, Lordotic
• M719GCL3D06L0: 6mm 3DP Cervical Interbody, Large, Lordotic
• M719GCL3D05S0: 5mm 3DP Cervical, Small, Lordotic
• M719GCL3D05L0: 5mm 3DP Cervical Interbody, Large, Lordotic
• M719GCC3D11S0: 11mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D10S0: 10mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D09S0: 9mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D08S0: 8mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D07S0: 7mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D06S0: 6mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D12S0: 12mm 3DP Cervical Interbody, Small, Convex
• M719GCC3D12L0: 12mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D11L0: 11mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D10L0: 10mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D09L0: 9mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D08L0: 8mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D07L0: 7mm 3DP Cervical Interbody, Large, Convex
• M719GCC3D06L0: 6mm 3DP Cervical Interbody, Large, Convex
• M719GAC3D12SP0: 12mm 3DP Stand-Alone Cervical Interbody, Small, Parallel
• M719GAC3D12SL0: 12mm 3DP Stand-Alone Cervical Interbody, Small, Lordotic
• M719GAC3D12LP0: 12mm 3DP Stand-Alone Cervical Interbody, Large, Parallel
• M719GAC3D12LL0: 12mm 3DP Stand-Alone Cervical Interbody, Large, Lordotic