MOJAVE Expandable Interbody System 7012-2132411C-G3

GUDID 10888857370531

Expandable Interbody with Set Screw, Size 13x24x11-14 mm

K2M, INC.

Vertebral body prosthesis

• Primary Device ID: 10888857370531
• NIH Device Record Key: 640f9244-9062-4f10-a339-ea8dfb7ab689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOJAVE Expandable Interbody System
• Version Model Number: 7012-2132411C-G3
• Catalog Number: 7012-2132411C-G3
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 13 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857370531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171097

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-12-18

On-Brand Devices [MOJAVE Expandable Interbody System]

• 10888857398627: Inserter Inner Shaft
• 10888857394100: Expandable Interbody Inserter, Size Long
• 10888857394025: Expansion Driver, Size Long
• 10888857391703: Inner Shaft
• 10888857391697: Driver, Size 8
• 10888857386518: Convex Trial, Size 13x28/32x15 mm
• 10888857386501: Convex Trial, Size 13x28/32x14 mm
• 10888857386495: Convex Trial, Size 13x28/32x13 mm
• 10888857386488: Convex Trial, Size 13x28/32x12 mm
• 10888857386471: Convex Trial, Size 13x28/32x11 mm
• 10888857386464: Convex Trial, Size 13x28/32x10 mm
• 10888857386457: Convex Trial, Size 13x28/32x9 mm
• 10888857386440: Convex Trial, Size 13x28/32x8 mm
• 10888857386433: Convex Trial, Size 13x28/32x7 mm
• 10888857386426: Convex Trial, Size 13x24/28x15 mm
• 10888857386419: Convex Trial, Size 13x24/28x14 mm
• 10888857386402: Convex Trial, Size 13x24/28x13 mm
• 10888857386396: Convex Trial, Size 13x24/28x12 mm
• 10888857386389: Convex Trial, Size 13x24/28x11 mm
• 10888857386372: Convex Trial, Size 13x24/28x10 mm
• 10888857386365: Convex Trial, Size 13x24/28x9 mm
• 10888857386358: Convex Trial, Size 13x24/28x8 mm
• 10888857386341: Convex Trial, Size 13x24/28x7 mm
• 10888857385788: Convex Trial, Size 11x28/32x15 mm
• 10888857385771: Convex Trial, Size 11x28/32x14 mm
• 10888857385764: Convex Trial, Size 11x28/32x13 mm
• 10888857385757: Convex Trial, Size 11x28/32x12 mm
• 10888857385740: Convex Trial, Size 11x28/32x11 mm
• 10888857385733: Convex Trial, Size 11x28/32x10 mm
• 10888857385726: Convex Trial, Size 11x28/32x9 mm
• 10888857385719: Convex Trial, Size 11x28/32x8 mm
• 10888857385702: Convex Trial, Size 11x28/32x7 mm
• 10888857384026: Convex Trial, Size 11x24/28x15 mm
• 10888857384019: Convex Trial, Size 11x24/28x14 mm
• 10888857384002: Convex Trial, Size 11x24/28x13 mm
• 10888857383999: Convex Trial, Size 11x24/28x12 mm
• 10888857383982: Convex Trial, Size 11x24/28x11 mm
• 10888857383975: Convex Trial, Size 11x24/28x10 mm
• 10888857383968: Convex Trial, Size 11x24/28x9 mm
• 10888857383951: Convex Trial, Size 11x24/28x8 mm
• 10888857383944: Convex Trial, Size 11x24/28x7 mm
• 10888857383265: Expandable Interbody with Set Screw, Size 13x32x9-12 mm
• 10888857383258: Expandable Interbody with Set Screw, Size 13x32x8-11 mm
• 10888857383241: Expandable Interbody with Set Screw, Size 13x32x7-10 mm
• 10888857383234: Expandable Interbody with Set Screw, Size 11x32x9-12 mm
• 10888857383227: Expandable Interbody with Set Screw, Size 11x32x8-11 mm
• 10888857383210: Expandable Interbody with Set Screw, Size 11x32x7-10 mm
• 10888857383203: Expandable Interbody with Set Screw, Size 13x28x9-12 mm
• 10888857383197: Expandable Interbody with Set Screw, Size 13x28x8-11 mm
• 10888857383180: Expandable Interbody with Set Screw, Size 13x28x7-10 mm