Aleutian Interbody System SP-3099-05

GUDID 10888857413177

Modular Trial, Size 11

K2M, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857413177
• NIH Device Record Key: c8234bd2-fa6a-45f0-8c4f-c4a0d7f426bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aleutian Interbody System
• Version Model Number: SP-3099-05
• Catalog Number: SP-3099-05
• 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: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857413177 [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

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

Moist Heat or Steam Sterilization

[10888857413177]

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]

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• 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