Cascadia™ Interbody System SP-2437-38

GUDID 10888857369771

Trial, Size 12x14x11 mm, 15°

K2M, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857369771
• NIH Device Record Key: ae207db1-dd9c-4aac-8dae-183f480bb685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cascadia™ Interbody System
• Version Model Number: SP-2437-38
• Catalog Number: SP-2437-38
• 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(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com
• Phone: +1(201)749-8943
• Email: christopher.tomea@stryker.com

Device Dimensions

• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 12 Millimeter
• Angle: 15 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857369771 [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

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

[10888857369771]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-16

On-Brand Devices [Cascadia™ Interbody System]

• 10888857415935: AN Lordotic - Oblique Inserter, Size 10 mm
• 10888857412170: Lateral Interbody, Size 22x40x20 mm, 28°
• 10888857412163: Lateral Interbody, Size 22x40x18 mm, 28°
• 10888857412156: Lateral Interbody, Size 22x40x16 mm, 28°
• 10888857412149: Lateral Interbody, Size 22x40x14 mm, 28°
• 10888857412132: Lateral Interbody, Size 22x40x18 mm, 22°
• 10888857412125: Lateral Interbody, Size 22x40x16 mm, 22°
• 10888857412118: Lateral Interbody, Size 22x40x14 mm, 22°
• 10888857412101: Lateral Interbody, Size 22x40x12 mm, 22°
• 10888857403895: AN MI Inserter, Size 10 mm Lordotic-Oblique
• 10888857382688: Implant Inserter, Inner Shaft,
• 10888857382671: Implant Inserter, Outer Shaft Assembly
• 10888857380271: Implant Inserter
• 10888857370159: Convex Trial, Size 12x14x15 mm
• 10888857370142: Convex Trial, Size 12x14x14 mm
• 10888857370135: Convex Trial, Size 12x14x13 mm
• 10888857370128: Convex Trial, Size 12x14x12 mm
• 10888857370111: Convex Trial, Size 12x14x11 mm
• 10888857370104: Convex Trial, Size 12x14,10 mm
• 10888857370098: Convex Trial, Size 12x14x9 mm
• 10888857370081: Convex Trial, Size 12x14x8 mm
• 10888857370074: Convex Trial, Size 12x14x7 mm
• 10888857370067: Convex Trial, Size 12x14x6 mm
• 10888857370050: Trial, Size 12x14x15 mm, 30°
• 10888857370043: Trial, Size 12x14x14 mm, 30°
• 10888857370036: Trial, Size 12x14X13 mm, 30°
• 10888857370029: Trial, Size 12x14x12 mm, 30°
• 10888857370012: Trial, Size 12x14x11 mm, 30°
• 10888857370005: Trial, Size 12x14x10 mm, 30°
• 10888857369993: Trial, Size 12x14x9 mm, 30°
• 10888857369986: Trial, Size 12x14x15 mm, 25°
• 10888857369979: Trial, Size 12x14x14 mm, 25°
• 10888857369962: Trial, Size 12x14X13 mm, 25°
• 10888857369955: Trial, Size 12x14x12 mm, 25°
• 10888857369948: Trial, Size 12x14x11 mm, 25°
• 10888857369931: Trial, Size 12x14x10 mm, 25°
• 10888857369924: Trial, Size 12x14x9 mm, 25°
• 10888857369917: Trial, Size 12x14x8 mm, 25°
• 10888857369900: Trial, Size 12x14x15 mm, 20°
• 10888857369894: Trial, Size 12x14x14 mm, 20°
• 10888857369887: Trial, Size 12x14X13 mm, 20°
• 10888857369870: Trial, Size 12x14x12 mm, 20°
• 10888857369863: Trial, Size 12x14x11 mm, 20°
• 10888857369856: Trial, Size 12x14x10 mm, 20°
• 10888857369849: Trial, Size 12x14x9 mm, 20°
• 10888857369832: Trial, Size 12x14x8 mm, 20°
• 10888857369825: Trial, Size 12x14x7 mm, 20°
• 10888857369818: Trial, Size 12x14x15 mm, 15°
• 10888857369801: Trial, Size 12x14x14 mm, 15°
• 10888857369795: Trial, Size 12x14X13 mm, 15°