TRIALTIS 5560124535F

GUDID 10705034594248

TRIALTIS Spine System Polyaxial Screw Fenestrated ø4.5mm x 35mm 5.5 and 6.0

Medos International Sàrl

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10705034594248
• NIH Device Record Key: 9de42d68-cd5b-4f5e-ab62-f924c1d330dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIALTIS
• Version Model Number: 5560-12-4535F
• Catalog Number: 5560124535F
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034594248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231479

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-23

On-Brand Devices [TRIALTIS]

• 10705034604671: TRIALTIS Spine System Polyaxial Favored Angle Screw Dual Lead Cannulated ø7.5mm x 50mm 5.5 and
• 10705034604664: TRIALTIS Spine System Polyaxial Favored Angle Screw Dual Lead Cannulated ø12mm x 110mm 5.5 an
• 10705034604060: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 75mm 5.5
• 10705034604053: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 65mm 5.5
• 10705034604046: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 55mm 5.5
• 10705034604039: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 45mm 5.5
• 10705034604022: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 40mm 5.5
• 10705034604015: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 35mm 5.5
• 10705034604008: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 30mm 5.5
• 10705034603995: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bullet and VIPER System End Feature
• 10705034603988: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 95mm 6
• 10705034603971: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 85mm 6
• 10705034603964: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 75mm 6
• 10705034603957: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 65mm 6
• 10705034603940: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 55mm 6
• 10705034603933: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 45mm 6
• 10705034603926: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 40mm 6
• 10705034603919: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 35mm 6
• 10705034603902: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø6.0mm x 30mm 6
• 10705034603896: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bullet and VIPER System End Feature
• 10705034603872: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 85mm 5.5
• 10705034603865: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 75mm 5.5
• 10705034603858: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 65mm 5.5
• 10705034603841: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 55mm 5.5
• 10705034603834: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 45mm 5.5
• 10705034603827: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 40mm 5.5
• 10705034603810: TRIALTIS Spine System Pre-Lordosed Rod Cobalt Chromium Alloy Bevel Ends ø5.5mm x 35mm 5.5
• 10705034603773: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Hex and VIPER System End Feature ø5.5mm x
• 10705034603742: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 95mm 5.5
• 10705034603735: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 85mm 5.5
• 10705034603728: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 45mm 6
• 10705034603711: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 40mm 6
• 10705034603704: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 35mm 6
• 10705034603698: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 30mm 6
• 10705034603681: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bullet and VIPER System End Feature ø5.5m
• 10705034603650: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Hex and VIPER System End Feature ø6.0mm x
• 10705034603643: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Hex and VIPER System End Feature ø6.0mm x
• 10705034603636: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Hex and VIPER System End Feature ø6.0mm x
• 10705034603629: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 95mm 6
• 10705034603612: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 85mm 6
• 10705034603605: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 75mm 6
• 10705034603599: TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø6.0mm x 65mm 6
• 10705034598178: TRIALTIS Spine System Polyaxial Screw Dual Lead Solid ø7mm x 80mm 5.5 and 6.0
• 10705034598154: TRIALTIS Spine System Polyaxial Screw Dual Lead Solid ø4.5mm x 60mm 5.5 and 6.0
• 10705034591766: TRIALTIS Spine System Polyaxial Favored Angle Screw Solid ø9.5mm x 60mm 5.5 and 6.0
• 10705034591223: TRIALTIS Spine System Polyaxial Favored Angle Screw Dual Lead Solid ø9.5mm x 65mm 5.5 and 6.0
• 10705034591216: TRIALTIS Spine System Polyaxial Favored Angle Screw Dual Lead Solid ø9.5mm x 60mm 5.5 and 6.0
• 10705034589688: TRIALTIS Spine System Polyaxial Screw Dual Lead Cannulated ø4.5mm x 50mm 5.5 and 6.0
• 10705034589633: TRIALTIS Spine System Polyaxial Screw Dual Lead Solid ø6mm x 50mm 5.5 and 6.0
• 10705034589237: TRIALTIS Spine System Polyaxial Favored Angle Screw Solid ø8mm x 80mm 5.5 and 6.0