ES2® Spinal System PRO-1406

GUDID 10888857581708

Inner Dilator

K2M, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857581708
• NIH Device Record Key: 453dbf66-156b-465a-9367-7a6725146415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ES2® Spinal System
• Version Model Number: PRO-1406
• Catalog Number: PRO-1406
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com
• Phone: +1(571)919-2000
• Email: christopher.tomea@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857581708 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

[10888857581708]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-06
• Device Publish Date: 2024-10-29

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• 10888857434325 - NIAGARA® Lateral Access System: 2025-08-27 Anterior Blade (Wide Long)
• 10888857434479 - NIAGARA® Lateral Access System: 2025-08-27 Blade Pin Shim