TRIALTIS Spine System 5560725112

GUDID 10705034646985

TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 10705034646985
• NIH Device Record Key: 42bf0c8e-66f8-4a2c-b419-6b2949898299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIALTIS Spine System
• Version Model Number: 5560725112
• Catalog Number: 5560725112
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +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
• 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	10705034646985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243249

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-29
• Device Publish Date: 2025-05-21

On-Brand Devices [TRIALTIS Spine System]

• 10705034647135: TRIALTIS Spine System Side by Side Connector, 11mm Open / Snap On ø5.5-6mm to 5.5-6.35mm
• 10705034647128: TRIALTIS Spine System Side by Side Connector, 15mm Open / Snap On ø5.5-6mm to 5.5-6.35mm
• 10705034647050: TRIALTIS Spine System Side by Side Connector, 21mm, Articulating Top Notch Open / Open ø5.5-6
• 10705034647043: TRIALTIS Spine System Side by Side Connector, 19mm, Articulating Top Notch Open / Open ø5.5-6
• 10705034647036: TRIALTIS Spine System Side by Side Connector, 17mm, Articulating Top Notch Open / Open ø5.5-6
• 10705034647029: TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
• 10705034647012: TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
• 10705034647005: TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Side Loading ø5.5-6mm to
• 10705034646992: TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
• 10705034646985: TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Side Loading ø5.5-6mm to
• 10705034646978: TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
• 10705034646961: TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
• 10705034646954: TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Side Loading ø5.5-6mm to
• 10705034646947: TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm