TiLock GSN148

GUDID M719GSN1480

4.8mm SN Tap

Genesys Orthopedics Systems LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M719GSN1480
• NIH Device Record Key: 0aa37f58-ca51-4627-a2e0-8f0977ff801c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLock
• Version Model Number: 1
• Catalog Number: GSN148
• 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: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com

Device Dimensions

• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter
• Width: 4.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GSN1480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103671

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

[M719GSN1480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-31
• Device Publish Date: 2023-07-21

On-Brand Devices [TiLock]

• M719GM581700: 70mm Modular XT Tulip Assembly
• M719GM5811000: 100mm Modular XT Tulip Assembly
• M719GM1320: Modular Thread-On Tulip Inserter
• M719GM1300: Modular TTS Rod Inserter
• M719GM1230: Modular Tulip Insert and Tug Wand
• M719GM1100: Modular Tulip Popper
• M719GM1020: Modular Tulip Insertion Wand
• M719GLC6130: Luer-Lock Connector
• M719GLC47620: DMDSA Half Torque
• M719GLC47610: DMDSA Half Torque
• M719GLC47220: DMDSA Counter Torque
• M719GLC47210: DMDSA Counter Torque
• M719GLC46820: DMDSA Modular Counter Torque
• M719GLC46810: DMDSA Modular Counter Torque
• M719GLC2120: MIS Thread-In Driver
• M719GL4240: Quarter Connect Slide Hammer
• M719GL304850: Torque Limiter Handle - 85 in/lb
• M719G88510: Single Domino
• M719GM8210: Modular Solid Lock Screw
• M719GM135SN0: SN Modular Locking Screw Driver
• M719GM135MS0: MS Modular Locking Screw Driver
• M719GM1350: Modular Locking Screw Driver No Sleeve
• M719GMSS50400: 5.0mm x 40mm Modular Solid Single Thread Screw
• M719GMSS50350: 5.0mm x 35mm Modular Solid Single Thread Screw
• M719GMSS50300: 5.0mm x 30mm Modular Solid Single Thread Screw
• M719GMSS50250: 5.0mm x 25mm Modular Solid Single Thread Screw
• M719GM1200: Modular Drill Guide
• M719GM1120: Cortical Drill Guide
• M719GM1250: Modular Tip Reamer
• M719G1501050: Pre-Bent Rod
• M719GL116TS0: Targeting Awl Stylet
• M719GL116TA0: Duckbill Targeting Awl
• M719GL11380: 1/4" Connector Probe - Curved
• M719GL11370: 1/4" Connector Probe - Straight
• M719GL11360: 1/4" Connector Probe - Slim Duckbill
• M719GL11350: 1/4" Connector Probe - Duckbill
• M719GL11340: 1/4" Connector Probe - Curved Tapered Lenke
• M719GL11330: 1/4" Connector Probe - Tapered Lenke
• M719GL11320: 1/4" Connector Probe - Curved Lenke
• M719GL11310: 1/4" Connector Probe - Lenke
• M719GM126S850: 8.5mm Modular Short Tap - Solid
• M719GM126S750: 7.5mm Modular Short Tap - Solid
• M719GM126S700: 7.0mm Modular Short Tap - Solid
• M719GM126S650: 6.5mm Modular Short Tap - Solid
• M719GM126S600: 6.0mm Modular Short Tap - Solid
• M719GM126S550: 5.5mm Modular Short Tap - Solid
• M719GM126S500: 5.0mm Modular Short Tap - Solid
• M719GM126S450: 4.5mm Modular Short Tap - Solid
• M719GM122S850: 8.5mm Solid Modular Tap
• M719GM122S750: 7.5mm Solid Modular Tap