176012006

GUDID 10705034035857

SURGICAL TITANIUM MESH MESH, ROUND 12 x 6mm

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 ID: 10705034035857
• NIH Device Record Key: fa82083b-77c2-4169-a057-9915c1acdab3
• Commercial Distribution Discontinuation: 2018-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 176012006
• Catalog Number: 176012006
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034035857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900138

FDA Product Code

• EZX: Mesh, surgical, metal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

[10705034035857]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-10-12
• Device Publish Date: 2015-09-24

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• 10705034103877 - EXPEDIUM: 2024-07-17 EXPEDIUM SPINE SYSTEM SPACER WASHER 4.5 2mm
• 10705034103884 - EXPEDIUM: 2024-07-17 EXPEDIUM SPINE SYSTEM SPLIT WASHER 4.5
• 10705034103891 - EXPEDIUM: 2024-07-17 EXPEDIUM SPINE SYSTEM POLYAXIAL WASHER 4.5
• 10705034103921 - EXPEDIUM: 2024-07-17 EXPEDIUM SPINE SYSTEM BOLT POLYAXIAL WASHER 4.5
• 10705034000442 - VSP: 2024-07-08 VSP SPINE SYSTEM CANNULATED SCREW CUTTER
• 10705034000930 - ISOLA: 2024-07-08 ISOLA SPINE SYSTEM TRANSVERSE ROD CONNECTOR 6.35mm