TiLock2 Pedicle Screw System GLC482-2

GUDID M719GLC48220

DMDSA Modular Screw Blade

Genesys Orthopedics Systems LLC

Hand-held surgical retractor, reusable

• Primary Device ID: M719GLC48220
• NIH Device Record Key: 7438f503-58e5-413c-a9d5-d6fdb1feb1d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLock2 Pedicle Screw System
• Version Model Number: 1
• Catalog Number: GLC482-2
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GLC48220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171838

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

Moist Heat or Steam Sterilization

[M719GLC48220]

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 [TiLock2 Pedicle Screw System]

• M719GLC48220: DMDSA Modular Screw Blade
• M719GLC48210: DMDSA Modular Screw Blade
• M719GLC4810: DMDSA Central Retractor Driver
• M719GLC4670: DMDSA Central Retractor
• M719GLC429S0: MIS Locking Star Setcap Starter - Short
• M719GLC125S0: K-Wire Tube - Short
• M719GLC4840: MIS Arc Distractor
• M719GL3270: 4-Sided Push Collar Ratchet Handle
• M719GL3220: 4-Sided Fixed Handle
• M719GLC7000: MIS Arc Distractor Variable Shaft