176117150

GUDID 10705034036465

SURGICAL TITANIUM MESH 17X22MM OVAL 150mm

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: 10705034036465
• NIH Device Record Key: 4bf6526c-bcb8-4b47-9f0d-e30786c0aaa7
• Commercial Distribution Discontinuation: 2018-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 176117150
• Catalog Number: 176117150
• 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	10705034036465 [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

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

Moist Heat or Steam Sterilization

[10705034036465]

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

Devices Manufactured by DEPUY SPINE, LLC

• 10705034003252 - ISOLA: 2024-04-05 ISOLA SPINE SYSTEM SPINAL WIRE WITH BUTTON 177.8mm
• 10705034003269 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM DOUBLE WIRE 304.8mm
• 10705034003276 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM BEADED WIRE 304.8mm
• 10705034202952 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM WIRE CUTTER
• 10705034302300 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM SMALL WIRE CUTTER
• 10705034314716 - NA: 2024-04-03 MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm
• 10705034484044 - NA: 2024-04-03 MODIFIED INSTRUMENT TREPHINE
• 10705034492353 - NA: 2024-04-03 MODIFIED INSTRUMENT BONE HARVESTER