174145000

GUDID 10705034017839

SURGICAL TITANIUM MESH ROUND 16 x 30mm

DEPUY SPINE, LLC

Metallic spinal interbody fusion cage
Primary Device ID10705034017839
NIH Device Record Key7f566ba3-bcdd-4a3b-9e93-43e246821d7b
Commercial Distribution Discontinuation2018-07-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number174145000
Catalog Number174145000
Company DUNS107105876
Company NameDEPUY SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
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
GS110705034017839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


[10705034017839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-10-12
Device Publish Date2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

10705034646947 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034646954 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm
10705034646961 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6mm
10705034646978 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034646985 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm
10705034646992 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6mm
10705034647005 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm
10705034647012 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6mm

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