3DP Cervical Interbody System GC3-THS-L06-SD

GUDID M719GC3THSL06SD0

Large 6mm 3DP Cervical Trial with Handle - Short Depth

Genesys Orthopedics Systems LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: M719GC3THSL06SD0
• NIH Device Record Key: 4b0c4c08-f537-4245-a24b-ef6f37877e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DP Cervical Interbody System
• Version Model Number: 1
• Catalog Number: GC3-THS-L06-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: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GC3THSL06SD0 [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

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

[M719GC3THSL06SD0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-07
• Device Publish Date: 2020-09-29

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