TRIALTIS Spine System 5161005086

GUDID 10705034589725

TRIALTIS Spine System Unilateral Inserter

DEPUY SPINE, LLC

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID10705034589725
NIH Device Record Key4a8796fc-39be-403a-84b4-c6e938436340
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIALTIS Spine System
Version Model Number5161005086
Catalog Number5161005086
Company DUNS107105876
Company NameDEPUY SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034589725 [Primary]

FDA Product Code

HWRDRIVER, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

[10705034589725]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

On-Brand Devices [TRIALTIS Spine System]

10705034647135TRIALTIS Spine System Side by Side Connector, 11mm Open / Snap On ø5.5-6mm to 5.5-6.35mm
10705034647128TRIALTIS Spine System Side by Side Connector, 15mm Open / Snap On ø5.5-6mm to 5.5-6.35mm
10705034647050TRIALTIS Spine System Side by Side Connector, 21mm, Articulating Top Notch Open / Open ø5.5-6
10705034647043TRIALTIS Spine System Side by Side Connector, 19mm, Articulating Top Notch Open / Open ø5.5-6
10705034647036TRIALTIS Spine System Side by Side Connector, 17mm, Articulating Top Notch Open / Open ø5.5-6
10705034647029TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034647012TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
10705034647005TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Side Loading ø5.5-6mm to
10705034646992TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
10705034646985TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Side Loading ø5.5-6mm to
10705034646978TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034646961TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6
10705034646954TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Side Loading ø5.5-6mm to
10705034646947TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034645780Double Side by Side Connector, 15mm
10705034645773Side by Side Connector, 15mm
10705034645766Double Side by Side Connector, 13mm
10705034645759Double Side by Side Connector, 11mm
10705034645742Double Side by Side Connector, 9mm
10705034645735Side by Side Connector, 13mm
10705034645728TRIALTIS Spine System Double End to End Connector Closed / Closed ø5.5-6mm to 5.5-6mm
10705034645681Side by Side Connector, 15mm
10705034634739TRIALTIS Spine System Connector Holder
10705034601601TRIALTIS Spine System Open Lateral Connector Fixed, Flanged ø5.5-6mm to 6mm x 30mm
10705034601571TRIALTIS Spine System Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 50mm
10705034601557TRIALTIS Spine System Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 30mm
10705034601472TRIALTIS Spine System Open Lateral Connector Fixed ø5.5-6mm to 6mm x 50mm
10705034601465TRIALTIS Spine System Open Lateral Connector Fixed ø5.5-6mm to 6mm x 30mm
10705034601458TRIALTIS Spine System Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 50mm
10705034601441TRIALTIS Spine System Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 30mm
10705034601373TRIALTIS Spine System Closed Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 50mm
10705034601359TRIALTIS Spine System Closed Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 30mm
10705034601274TRIALTIS Spine System Closed Lateral Connector Fixed ø5.5-6mm to 6mm x 50mm
10705034601267TRIALTIS Spine System Closed Lateral Connector Fixed ø5.5-6mm to 6mm x 30mm
10705034601250TRIALTIS Spine System Closed Lateral Connector Adjustable ø5.5-6mm to 6mm x 50mm
10705034601243TRIALTIS Spine System Closed Lateral Connector Adjustable ø5.5-6mm to 6mm x 30mm
10705034597904TRIALTIS Spine System Core Connector Caddy 2
10705034592428TRIALTIS Spine System Sequential Reducer, Short Integrated Handle Inner 5.5 and 6.0
10705034589725TRIALTIS Spine System Unilateral Inserter
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