Skye Cervical Plate System CP653

GUDID 00195860010099

65mm 3 Level Plate

Evolution Spine LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00195860010099
• NIH Device Record Key: 8b3529f9-f1a6-4a6a-b990-a9da1e88b900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skye Cervical Plate System
• Version Model Number: CP653
• Catalog Number: CP653
• Company DUNS: 116940934
• Company Name: Evolution Spine LLC
• 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(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com

Device Dimensions

• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860010099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173375

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

[00195860010099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-10
• Device Publish Date: 2021-06-02

On-Brand Devices [Skye Cervical Plate System]

• 00195860010587: Instrument Tray 1
• 00195860010600: Fixed / Variable Screw Caddy
• 00195860010594: Plate Caddy
• 00195860010570: Skye Tray Lid
• 00195860010563: Dia 2.0mm x 17mm
• 00195860010556: Dia 2.0mm x 15mm
• 00195860010549: Dia 2.0mm x 13mm
• 00195860010532: Plate Holder
• 00195860010525: Screw Driver (w/handle)
• 00195860010518: Cover Turning Driver (w/handle)
• 00195860010501: Fixed Drill Guide
• 00195860010495: Variable Drill Guide
• 00195860010488: Screw Driver
• 00195860010471: Awl
• 00195860010464: Cover Turning Driver
• 00195860010457: Cervical Plate Fixation Pin
• 00195860010440: Dia 4.25mm x 18mm Variable
• 00195860010433: Dia 4.25mm x 16mm Variable
• 00195860010426: Dia 4.25mm x 14mm Variable
• 00195860010419: Dia 4.25mm x 12mm Variable
• 00195860010402: Dia 3.75mm x 18mm Variable
• 00195860010396: Dia 3.75mm x 16mm Variable
• 00195860010389: Dia 3.75mm x 14mm Variable
• 00195860010372: Dia 3.75mm x 12mm Variable
• 00195860010365: Dia 4.25mm x 18mm Fixed
• 00195860010358: Dia 4.25mm x 16mm Fixed
• 00195860010341: Dia 4.25mm x 14mm Fixed
• 00195860010334: Dia 4.25mm x 12mm Fixed
• 00195860010327: Dia 3.75mm x 18mm Fixed
• 00195860010310: Dia 3.75mm x 16mm Fixed
• 00195860010303: Dia 3.75mm x 14mm Fixed
• 00195860010297: Dia 3.75mm x 12mm Fixed
• 00195860010280: 110mm 5 Level Plate
• 00195860010273: 105mm 5 Level Plate
• 00195860010266: 100mm 5 Level Plate
• 00195860010259: 95mm 5 Level Plate
• 00195860010242: 90mm 5 Level Plate
• 00195860010235: 85mm 5 Level Plate
• 00195860010228: 80mm 5 Level Plate
• 00195860010211: 75mm 5 Level Plate
• 00195860010204: 84mm 4 Level Plate
• 00195860010198: 80mm 4 Level Plate
• 00195860010181: 76mm 4 Level Plate
• 00195860010174: 72mm 4 Level Plate
• 00195860010167: 68mm 4 Level Plate
• 00195860010150: 64mm 4 Level Plate
• 00195860010143: 60mm 4 Level Plate
• 00195860010136: 55mm 4 Level Plate
• 00195860010129: 50mm 4 Level Plate
• 00195860010112: 71mm 3 Level Plate