FALCON Anterior Cervical Plate

GUDID 00840996100014

Falcon Plate, 1 Level, 12

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840996100014
• NIH Device Record Key: 67c9c3df-f172-4e6a-8f62-8ff08d998f06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FALCON Anterior Cervical Plate
• Version Model Number: AT10-1012
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996100014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091926

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

Moist Heat or Steam Sterilization

[00840996100014]

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: 2017-01-19

On-Brand Devices [FALCON Anterior Cervical Plate]

• 00840996173650: Falcon Plate, 4 Level, 92
• 00840996173643: Falcon Plate, 4 Level, 88
• 00840996173636: Falcon Plate, 2 Level, 42
• 00840996100045: Falcon Plate, 1 Level, 18
• 00840996100038: Falcon Plate, 1 Level, 16
• 00840996100021: Falcon Plate, 1 Level, 14
• 00840996100014: Falcon Plate, 1 Level, 12
• 00840996100007: Falcon Plate, 1 Level, 10