| Primary Device ID | 10705034646961 |
| NIH Device Record Key | 2e903363-165a-4b85-9d2c-7c2532dfb687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIALTIS Spine System |
| Version Model Number | 5560725123 |
| Catalog Number | 5560725123 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034646961 [Primary] |
| NKB | Thoracolumbosacral pedicle screw system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-29 |
| Device Publish Date | 2025-05-21 |
| 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 |