174168000

GUDID 10705034018140

SURGICAL TITANIUM MESH BONE SCREW 3 x 6.5mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034018140
• NIH Device Record Key: 0cb6b037-5d4a-4705-959f-8520603d8828
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 174168000
• Catalog Number: 174168000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034018140 [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

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

Moist Heat or Steam Sterilization

[10705034018140]

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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• 10705034576480 - N/A: 2024-09-20 MODIFIED INSTRUMENT DRIVER
• 10705034576534 - N/A: 2024-09-20 MODIFIED INSTRUMENT TAP
• 10705034576633 - N/A: 2024-09-19 MODIFIED INSTRUMENT OSTEOTOME
• 10705034576657 - N/A: 2024-09-19 MODIFIED INSTRUMENT DISTRACTOR LEG, SHORT
• 10705034576688 - N/A: 2024-09-19 MODIFIED INSTRUMENT ACDF SHIM