TRIALTIS Spine System 5161031024

GUDID 10705034647760

TRIALTIS Spine System Implant Outer Case

Medos International Sàrl

Instrument tray, reusable

• Primary Device ID: 10705034647760
• NIH Device Record Key: 0115da2c-d98f-4427-895d-20dc1e6c2fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIALTIS Spine System
• Version Model Number: 5161031024
• Catalog Number: 5161031024
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034647760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253249

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

[10705034647760]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

On-Brand Devices [TRIALTIS Spine System]

• 10705034647760: TRIALTIS Spine System Implant Outer Case
• 10705034647753: TRIALTIS Spine System Generic Outer Lid, Half
• 10705034647746: TRIALTIS Spine System Generic Outer Lid
• 10705034647227: TRIALTIS Spine System Open Hook Pedicle, ISOLA 6.5mm 5.5 and 6.0
• 10705034644097: TRIALTIS Spine System Uniplanar Screw Cannulated ø7.0mm x 60mm5.5 and 6.0
• 10705034644028: TRIALTIS Spine System Uniplanar Screw Cannulated ø7.0mm x 25mm5.5 and 6.0
• 10705034643861: TRIALTIS Spine System Uniplanar Screw Cannulated ø6.5mm x 60mm5.5 and 6.0
• 10705034643779: TRIALTIS Spine System Uniplanar Screw Cannulated ø6.0mm x 60mm5.5 and 6.0
• 10705034642420: TRIALTIS Spine System Uniplanar Screw Solid ø7.0mm x 60mm5.5 and 6.0
• 10705034608372: TRIALTIS Spine System Uniplanar Screw Solid ø5.5mm x 55mm5.5 and 6.0
• 10705034608259: TRIALTIS Spine System Uniplanar Screw Solid ø6.0mm x 60mm5.5 and 6.0
• 10705034607443: TRIALTIS Spine System Uniplanar Screw Solid ø4.5mm x 55mm5.5 and 6.0
• 10705034607122: TRIALTIS Spine System Uniplanar Screw Solid ø5.0mm x 55mm5.5 and 6.0