ARI™ Anterior Staple System 1801-D1515

GUDID 10888857025110

Single Hole Staple

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857025110
• NIH Device Record Key: 1b326a72-0e7a-4bc3-b763-a3bd863fcc79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARI™ Anterior Staple System
• Version Model Number: 1801-D1515
• Catalog Number: 1801-D1515
• 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: true
• 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
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857025110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100851

FDA Product Code

• OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

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

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

[10888857025110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [ARI™ Anterior Staple System]

• 10888857025196: Washer
• 10888857025189: Dual Hole Staple (Right)
• 10888857025172: Dual Hole Staple (Left)
• 10888857025165: Dual Hole Staple (Right)
• 10888857025158: Dual Hole Staple (Left)
• 10888857025141: Dual Hole Staple (Right)
• 10888857025134: Dual Hole Staple (Left)
• 10888857025127: Single Hole Staple
• 10888857025110: Single Hole Staple