Ambassador

GUDID 00840996157490

AMBASSADOR,PLATE,2L,26

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: 00840996157490
• NIH Device Record Key: bd16e043-c1cf-4c2a-b793-c43586bc936a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambassador
• Version Model Number: 05-100-02-0026
• 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: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter
• Length: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996157490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143576

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

Moist Heat or Steam Sterilization

[00840996157490]

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: 2017-06-23