BLUE RIDGE™ Hybrid Cervical Plate System 3914-43F46

GUDID 10888857085671

Constrained Plate, 3 Level, Size 3 Level 46 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 Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857085671
• NIH Device Record Key: 8dfab62b-d5f5-461f-b0ab-783d77eebca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUE RIDGE™ Hybrid Cervical Plate System
• Version Model Number: 3914-43F46
• Catalog Number: 3914-43F46
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter
• Device Size Text, specify: 0
• Length: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857085671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113329

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

Moist Heat or Steam Sterilization

[10888857085671]

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: 2016-12-02

On-Brand Devices [BLUE RIDGE™ Hybrid Cervical Plate System]

• 10888857085671: Constrained Plate, 3 Level, Size 3 Level 46 mm
• 10888857085657: Constrained Plate, 3 Level, Size 3 Level 45 mm