TRIALTIS 5560048065C
GUDID 10705034594132
TRIALTIS Spine System Polyaxial Sacral Alar Iliac Screw Cannulated ø8mm x 65mm 5.5 and 6.0
Medos International Sàrl
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10705034594132 |
| NIH Device Record Key | 81c35573-5371-4989-9b16-24a0ab02940e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIALTIS |
| Version Model Number | 5560-04-8065C |
| Catalog Number | 5560048065C |
| 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
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034594132 [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 |
Trademark Results [TRIALTIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIALTIS 97257918 not registered Live/Pending |
DePuy Synthes, Inc. 2022-02-08 |
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