NILE™ Spinal System 3711-G13610

GUDID 10888857083844

Wire Pack, Qty 4

K2M, INC.

Orthopaedic bone wire

• Primary Device ID: 10888857083844
• NIH Device Record Key: 4743da3e-5f41-4994-880e-48c5e0fdc5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NILE™ Spinal System
• Version Model Number: 3711-G13610
• Catalog Number: 3711-G13610
• Company DUNS: 146060863
• Company Name: K2M, INC.
• 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(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857083844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103797

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

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

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

[10888857083844]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-30

On-Brand Devices [NILE™ Spinal System]

• 10888857083844: Wire Pack, Qty 4
• 10888857083837: Wire Pack, Qty 4