Lumbar Plate System GLP-10000-019

GUDID M719GLP100000190

19mm Lumbar Plate

Genesys Orthopedics Systems LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M719GLP100000190
• NIH Device Record Key: 5351dcd5-6be8-4be1-b71b-eca056acbe5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Plate System
• Version Model Number: 1
• Catalog Number: GLP-10000-019
• 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
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Dimensions

• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter
• Length: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GLP100000190 [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

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

[M719GLP100000190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [Lumbar Plate System]

• M719GLP100000250: 25mm Lumbar Plate
• M719GLP100000230: 23mm Lumbar Plate
• M719GLP100000210: 21mm Lumbar Plate
• M719GLP100000190: 19mm Lumbar Plate
• M719GLP100000170: 17mm Lumbar Plate
• M719GLP100000150: 15mm Lumbar Plate
• M719GLPV55320: 5.5mm x 32mm Lumbar Plate Variable Screw
• M719GLPV55280: 5.5mm x 28mm Lumbar Plate Variable Screw
• M719GLPV55240: 5.5mm x 24mm Lumbar Plate Variable Screw
• M719GLPV55200: 5.5mm x 20mm Lumbar Plate Variable Screw
• M719GLP1630: Lumbar Plate LP Basic Screwdriver
• M719GLP1620: Lumbar Plate Angled Awl Guide
• M719GLP1610: Lumbar Plate Jointed Driver
• M719GLP1600: Lumbar Plate Jointed Awl
• M719GLP1590: Lumbar Plate Helios Driver - Assembly
• M719GLP15420: Lumbar Plate Shielded Awl, No Spring
• M719GLP10155320: 5.5mm x 32mm Lumbar Screw
• M719GLP10155280: 5.5mm x 28mm Lumbar Screw
• M719GLP10155240: 5.5mm x 24mm Lumbar Screw
• M719GLP10155210: 5.5 x 21mm Lumbar Screw
• M719GLP10101320: 32mm Lumbar Plate Drill
• M719GLP10101280: 28mm Lumbar Plate Drill
• M719GLP10101240: 24mm Lumbar Plate Drill