CASCADIA Interbody System 6101-90138

GUDID 10888857272170

Implant Inserter

K2M, INC.

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• Primary Device ID: 10888857272170
• NIH Device Record Key: 856ef304-7a1d-4149-94b5-ac8a3243876d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASCADIA Interbody System
• Version Model Number: 6101-90138
• Catalog Number: 6101-90138
• 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: 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	10888857272170 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

[10888857272170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [CASCADIA Interbody System]

• 10888857551817: Inserter Inner Shaft
• 10888857551800: Inserter Outer Shaft
• 10888857462168: ALIF Trial Inserter
• 10888857431461: Tapered Driver Size 20
• 10888857383838: Inserter Blade Tether
• 10888857383821: Plate Assembly Final Tightener
• 10888857383715: Plate Assembly Driver Tapered
• 10888857320673: Graft Contaiment Ramp Size 22 mm, Stop
• 10888857272170: Implant Inserter
• 10888857562943: Caddy
• 10888857562936: Caddy
• 10888857562929: Caddy
• 10888857562912: Caddy
• 10888857557277: Inserter ATP, 35°
• 10888857557260: Inserter ATP, 25°
• 10888857556072: Inserter Inner Shaft ATP
• 10888857554269: Untightening Ring Inserter
• 07613327506808: Case Lid
• 07613327506761: Instrument Case
• 07613327506624: Instrument Case
• 07613327506570: Instrument Case