ALEUTIAN Cervical SP-4255-02

GUDID 10888857515680

Trial, Size 11.5x14.5x6 mm, 7°

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

• Primary Device ID: 10888857515680
• NIH Device Record Key: 48d4a464-5318-4675-8912-f64dc5f4ac73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALEUTIAN Cervical
• Version Model Number: SP-4255-02
• Catalog Number: SP-4255-02
• 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(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 Dimensions

• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Length: 11.5 Millimeter
• Width: 14.5 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857515680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133614

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

[10888857515680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [ALEUTIAN Cervical]

• 10888857515888: Rasp, Size 11.5x14.5x15 mm, 7°
• 10888857515871: Rasp, Size 11.5x14.5x14 mm, 7°
• 10888857515864: Rasp, Size 11.5x14.5x13 mm, 7°
• 10888857515857: Rasp, Size 11.5x14.5x12 mm, 7°
• 10888857515840: Rasp, Size 11.5x14.5x11 mm, 7°
• 10888857515833: Rasp, Size 11.5x14.5x10 mm, 7°
• 10888857515826: Rasp, Size 11.5x14.5x9 mm, 7°
• 10888857515819: Rasp, Size 11.5x14.5x8 mm, 7°
• 10888857515802: Rasp, Size 11.5x14.5x7 mm, 7°
• 10888857515796: Rasp, Size 11.5x14.5x6 mm, 7°
• 10888857515789: Rasp, Size 11.5x14.5x5 mm, 7°
• 10888857515772: Trial, Size 11.5x14.5x15 mm, 7°
• 10888857515765: Trial, Size 11.5x14.5x14 mm, 7°
• 10888857515758: Trial, Size 11.5x14.5x13 mm, 7°
• 10888857515741: Trial, Size 11.5x14.5x12 mm, 7°
• 10888857515734: Trial, Size 11.5x14.5x11 mm, 7°
• 10888857515727: Trial, Size 11.5x14.5x10 mm, 7°
• 10888857515710: Trial, Size 11.5x14.5x9 mm, 7°
• 10888857515703: Trial, Size 11.5x14.5x8 mm, 7°
• 10888857515697: Trial, Size 11.5x14.5x7 mm, 7°
• 10888857515680: Trial, Size 11.5x14.5x6 mm, 7°
• 10888857515673: Trial, Size 11.5x14.5x5 mm, 7°