176012014

GUDID 10705034035932

SURGICAL TITANIUM MESH MESH, SHORT ROUND 12 x 14mm

DEPUY SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 10705034035932
• NIH Device Record Key: d4fb4a56-3db5-4c09-beab-3948ec9d77f6
• Commercial Distribution Discontinuation: 2018-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 176012014
• Catalog Number: 176012014
• 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	10705034035932 [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

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

Moist Heat or Steam Sterilization

[10705034035932]

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

• 10705034577562 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 40mm
• 10705034577579 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 60mm
• 10705034577586 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 80mm
• 10705034577593 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 100mm
• 10705034577609 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 120mm
• 10705034577616 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 140mm
• 10705034577623 - N/A: 2025-03-19 MODIFIED INSTRUMENT RETRACTOR BLADE 35mm x 160mm
• 10705034577630 - N/A: 2025-03-19 MODIFIED INSTRUMENT SET SCREW INSERTER