Primary Device ID | 10705034634739 |
NIH Device Record Key | 4b2b654f-c911-4e98-8b32-adca19743f2e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TRIALTIS Spine System |
Version Model Number | 5161005057 |
Catalog Number | 5161005057 |
Company DUNS | 107105876 |
Company Name | DEPUY SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705034634739 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
[10705034634739]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-25 |
Device Publish Date | 2025-07-17 |
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 |
10705034645780 | Double Side by Side Connector, 15mm |
10705034645773 | Side by Side Connector, 15mm |
10705034645766 | Double Side by Side Connector, 13mm |
10705034645759 | Double Side by Side Connector, 11mm |
10705034645742 | Double Side by Side Connector, 9mm |
10705034645735 | Side by Side Connector, 13mm |
10705034645728 | TRIALTIS Spine System Double End to End Connector Closed / Closed ø5.5-6mm to 5.5-6mm |
10705034645681 | Side by Side Connector, 15mm |
10705034634739 | TRIALTIS Spine System Connector Holder |
10705034601601 | TRIALTIS Spine System Open Lateral Connector Fixed, Flanged ø5.5-6mm to 6mm x 30mm |
10705034601571 | TRIALTIS Spine System Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 50mm |
10705034601557 | TRIALTIS Spine System Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 30mm |
10705034601472 | TRIALTIS Spine System Open Lateral Connector Fixed ø5.5-6mm to 6mm x 50mm |
10705034601465 | TRIALTIS Spine System Open Lateral Connector Fixed ø5.5-6mm to 6mm x 30mm |
10705034601458 | TRIALTIS Spine System Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 50mm |
10705034601441 | TRIALTIS Spine System Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 30mm |
10705034601373 | TRIALTIS Spine System Closed Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 50mm |
10705034601359 | TRIALTIS Spine System Closed Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 30mm |
10705034601274 | TRIALTIS Spine System Closed Lateral Connector Fixed ø5.5-6mm to 6mm x 50mm |
10705034601267 | TRIALTIS Spine System Closed Lateral Connector Fixed ø5.5-6mm to 6mm x 30mm |
10705034601250 | TRIALTIS Spine System Closed Lateral Connector Adjustable ø5.5-6mm to 6mm x 50mm |
10705034601243 | TRIALTIS Spine System Closed Lateral Connector Adjustable ø5.5-6mm to 6mm x 30mm |
10705034597904 | TRIALTIS Spine System Core Connector Caddy 2 |
10705034592428 | TRIALTIS Spine System Sequential Reducer, Short Integrated Handle Inner 5.5 and 6.0 |
10705034589725 | TRIALTIS Spine System Unilateral Inserter |