Lumbar Plate GLP111-10

GUDID M719GLP111100

Lumbar Plate Temporary Tacking Pin - 10mm

Genesys Orthopedics Systems LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: M719GLP111100
• NIH Device Record Key: 47d937d0-d1e2-4845-9f66-85f3a6970221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Plate
• Version Model Number: 1
• Catalog Number: GLP111-10
• 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

Device Dimensions

• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GLP111100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173885

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M719GLP111100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-10
• Device Publish Date: 2020-01-02

On-Brand Devices [Lumbar Plate]

• M719GLPV60540: 54mm Lumbar Plate Variable Rescue Screw
• M719GLPV60500: 50mm Lumbar Plate Variable Rescue Screw
• M719GLPV60460: 46mm Lumbar Plate Variable Rescue Screw
• M719GLPV60420: 42mm Lumbar Plate Variable Rescue Screw
• M719GLPV60380: 38mm Lumbar Plate Variable Rescue Screw
• M719GLPV60340: 34mm Lumbar Plate Variable Rescue Screw
• M719GLPV60300: 30mm Lumbar Plate Variable Rescue Screw
• M719GLPV60260: 26mm Lumbar Plate Variable Rescue Screw
• M719GLPV60220: 22mm Lumbar Plate Variable Rescue Screw
• M719GLPV60180: 18mm Lumbar Plate Variable Rescue Screw
• M719GLPV55540: 5.5mm x 54mm Lumbar Plate Variable Screw
• M719GLPV55500: 5.5mm x 50mm Lumbar Plate Variable Screw
• M719GLPV55460: 5.5mm x 46mm Lumbar Plate Variable Screw
• M719GLPV55420: 5.5mm x 42mm Lumbar Plate Variable Screw
• M719GLPV55380: 5.5mm x 30mm Lumbar Plate Variable Screw
• M719GLPV55340: 5.5mm x 34mm Lumbar Plate Variable Screw
• M719GLPV55300: 5.5mm x 30mm Lumbar Plate Variable Screw
• M719GLPV55260: 5.5mm x 26mm Lumbar Plate Variable Screw
• M719GLPV55220: 5.5mm x 22mm Lumbar Plate Variable Screw
• M719GLPV55180: 5.5mm x 18mm Lumbar Plate Variable Screw
• M719GLPF60540: 54mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60500: 50mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60460: 46mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60420: 42mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60380: 38mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60340: 34mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60300: 30mm Lumbar Plate Fixed Screw
• M719GLPF60260: 26mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60220: 22mm Lumbar Plate Fixed Rescue Screw
• M719GLPF60180: 18mm Lumbar Plate Fixed Rescue Screw
• M719GLPF55540: 5.5mm x 54mm Lumbar Plate Fixed Screw
• M719GLPF55500: 5.5mm x 50mm Lumbar Plate Fixed Screw
• M719GLPF55460: 5.5mm x 46mm Lumbar Plate Fixed Screw
• M719GLPF55420: 5.5mm x 42mm Lumbar Plate Fixed Screw
• M719GLPF55380: 5.5mm x 38mm Lumbar Plate Fixed Screw
• M719GLPF55340: 5.5mm x 34mm Lumbar Plate Fixed Screw
• M719GLPF55300: 5.5mm x 30mm Lumbar Plate Fixed Screw
• M719GLPF55260: 5.5mm x 26mm Lumbar Plate Fixed Screw
• M719GLPF55220: 5.5mm x 22mm Lumbar Plate Fixed Screw
• M719GLPF55180: 5.5mm x 18mm Lumbar Plate Fixed Screw
• M719GLP2020: Lumbar Plate Straight Removal Sleeve
• M719GLP2010: Lumbar Plate Straight Screw Removal Tool
• M719GLP1120: Lumbar Plate Inserter
• M719GLP1000: Lumbar Plate-ALIF Inserter
• M719GLPB400: 40mm Berm Sacral Plate
• M719GLPB370: 37mm Berm Sacral Plate
• M719GLPB340: 34mm Berm Sacral Plate
• M719GLPB310: 31mm Berm Sacral Plate
• M719GLPB280: 28mm Berm Sacral Plate
• M719GLPB250: 25mm Berm Sacral Plate