DENALI® MI Spinal System M101-18535

GUDID 10888857148567

Monoaxial Screw, Cannulated, Size Ø8.5x35 mm

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857148567
• NIH Device Record Key: 2e0daa1c-8519-43d0-98d9-acdb2b8d3efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENALI® MI Spinal System
• Version Model Number: M101-18535
• Catalog Number: M101-18535
• 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: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@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

Device Dimensions

• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857148567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112037

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

[10888857148567]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-06
• Device Publish Date: 2018-11-05

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