Aleutian Interbody System SP-3099-08

GUDID 10888857413207

Modular Trial, Size 14

K2M, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857413207
• NIH Device Record Key: 6e363ff5-0a69-4f6c-b55e-5df0bc9e4884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aleutian Interbody System
• Version Model Number: SP-3099-08
• Catalog Number: SP-3099-08
• 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: 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(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
• 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	10888857413207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133614

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

[10888857413207]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-17
• Device Publish Date: 2018-07-17

On-Brand Devices [Aleutian Interbody System]

• 10888857413252: Modular Trial, Size 19
• 10888857413245: Modular Trial, Size 18
• 10888857413238: Modular Trial, Size 17
• 10888857413221: Modular Trial, Size 16
• 10888857413214: Modular Trial, Size 15
• 10888857413207: Modular Trial, Size 14
• 10888857413191: Modular Trial, Size 13
• 10888857413184: Modular Trial, Size 12
• 10888857413177: Modular Trial, Size 11
• 10888857413160: Modular Trial, Size 10
• 10888857413153: Modular Trial, Size 9
• 10888857413146: Modular Trial, Size 8
• 10888857413139: Modular Trial, Size 7