Vusion TS Plus

GUDID 00822409026616

28 mm x 9.5 mm x 18 mm 6 Degree Lordotic

Ortho Development Corporation

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00822409026616
• NIH Device Record Key: 7006ef5a-44f4-442b-be9e-2bd4ac44151f
• Commercial Distribution Discontinuation: 2016-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vusion TS Plus
• Version Model Number: 551-5618
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409026616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062666

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00822409026616]

Moist Heat or Steam Sterilization

[00822409026616]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-31

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• 00822409083541 - N/A: 2024-04-15 12/14 Femoral Head Trial 22, -3
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• 00822409083565 - N/A: 2024-04-15 12/14 Femoral Head Trial 26, +3
• 00822409083572 - N/A: 2024-04-15 12/14 Femoral Head Trial 26, +6