176804322

GUDID 10705034051543

SURGICAL TITANIUM MESH ENDCAP 23 x 27mm

DEPUY SPINE, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID10705034051543
NIH Device Record Key292ae346-1857-4490-a41a-ce857b59a57b
Commercial Distribution Discontinuation2018-07-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number176804322
Catalog Number176804322
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
GS110705034051543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZXMesh, surgical, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

Moist Heat or Steam Sterilization


[10705034051543]

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

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10705034581125 - N/A2024-05-16 MODIFIED INSTRUMENT COBB ELEVATOR,ANGLED 12.7mm
10705034581132 - N/A2024-05-16 MODIFIED INSTRUMENT COBB ELEVATOR,STRAIGHT 20mm
10705034581149 - N/A2024-05-16 MODIFIED INSTRUMENT COBB ELEVATOR,ANGLED 20mm
10705034581163 - N/A2024-05-16 MODIFIED INSTRUMENT TAPERED TAP 3.0mm/3.5mm
10705034581170 - N/A2024-05-16 MODIFIED INSTRUMENT TAPERED TAP 3.5mm/4.0mm
10705034581279 - N/A2024-05-16 MODIFIED INSTRUMENT CURETTE 6mm x 9mm

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