Blue Ridge Hybrid Cervical Plate System 3901-04016C

GUDID 10888857083912

Self-Tapping, Variable Screw

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857083912
• NIH Device Record Key: da7311cf-9c92-4aac-b044-2050d3d9ee0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Ridge Hybrid Cervical Plate System
• Version Model Number: 3901-04016C
• Catalog Number: 3901-04016C
• 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
• 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 Dimensions

• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857083912 [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

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

Moist Heat or Steam Sterilization

[10888857083912]

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 [Blue Ridge Hybrid Cervical Plate System]

• 10888857087088: Constrained Plate, 4 Level
• 10888857087071: Constrained Plate, 4 Level
• 10888857087002: Constrained Plate, 4 Level
• 10888857086999: Constrained Plate, 4 Level
• 10888857086920: Constrained Plate, 4 Level
• 10888857086913: Constrained Plate, 4 Level
• 10888857086845: Constrained Plate, 4 Level
• 10888857086838: Constrained Plate, 4 Level
• 10888857086760: Constrained Plate, 4 Level
• 10888857086753: Constrained Plate, 4 Level
• 10888857086685: Constrained Plate, 4 Level
• 10888857086678: Constrained Plate, 4 Level
• 10888857086609: Constrained Plate, 4 Level
• 10888857086593: Constrained Plate, 4 Level
• 10888857086302: Constrained Plate, 3 Level
• 10888857086296: Constrained Plate, 3 Level
• 10888857086241: Constrained Plate, 3 Level
• 10888857086234: Constrained Plate, 3 Level
• 10888857086180: Constrained Plate, 3 Level
• 10888857086173: Constrained Plate, 3 Level
• 10888857086128: Constrained Plate, 3 Level
• 10888857086111: Constrained Plate, 3 Level
• 10888857086067: Constrained Plate, 3 Level
• 10888857086050: Constrained Plate, 3 Level
• 10888857086005: Constrained Plate, 3 Level
• 10888857085992: Constrained Plate, 3 Level
• 10888857085947: Constrained Plate, 3 Level
• 10888857085930: Constrained Plate, 3 Level
• 10888857085886: Constrained Plate, 3 Level
• 10888857085879: Constrained Plate, 3 Level
• 10888857085824: Constrained Plate, 3 Level
• 10888857085817: Constrained Plate, 3 Level
• 10888857085763: Constrained Plate, 3 Level
• 10888857085756: Constrained Plate, 3 Level
• 10888857085701: Constrained Plate, 3 Level
• 10888857085695: Constrained Plate, 3 Level
• 10888857085602: Constrained Plate, 2 Level
• 10888857085596: Constrained Plate, 2 Level
• 10888857085541: Constrained Plate, 2 Level
• 10888857085534: Constrained Plate, 2 Level
• 10888857085480: Constrained Plate, 2 Level
• 10888857085473: Constrained Plate, 2 Level
• 10888857085428: Constrained Plate, 2 Level
• 10888857085411: Constrained Plate, 2 Level
• 10888857085367: Constrained Plate, 2 Level
• 10888857085350: Constrained Plate, 2 Level
• 10888857085305: Constrained Plate, 2 Level
• 10888857085299: Constrained Plate, 2 Level
• 10888857085244: Constrained Plate, 2 Level
• 10888857085237: Constrained Plate, 2 Level