176804012

GUDID 10705034051437

SURGICAL TITANIUM MESH ENDCAP, ROUND 12mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 10705034051437
• NIH Device Record Key: dcfbe55d-65b4-40d6-acc6-9cdd5b6c30af
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 176804012
• Catalog Number: 176804012
• 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
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034051437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003043

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

[10705034051437]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-06
• Device Publish Date: 2015-09-24

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• 10705034547640 - N/A: 2024-09-11 MODIFIED INSTRUMENT FINAL TIGHTENER X25
• 10705034547695 - N/A: 2024-09-11 MODIFIED INSTRUMENT FACILITATOR
• 10705034547862 - N/A: 2024-09-11 MODIFIED INSTRUMENT FACILITATOR, SHORT TAB
• 10705034491202 - NA: 2024-08-20 MODIFIED INSTRUMENT GRAFT PUSHER
• 10705034575964 - N/A: 2024-08-12 MODIFIED INSTRUMENT DRIVER X 25
• 10705034576787 - N/A: 2024-08-12 MODIFIED INSTRUMENT BLADE HOLDER HANDLE