Tx™ TX10102810

GUDID M711TX101028101

HA PEEK, Ta

Innovasis, Inc.

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• Primary Device ID: M711TX101028101
• NIH Device Record Key: e6697d90-bf6b-4caa-9b71-4b1daed69112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tx™
• Version Model Number: TX10102810
• Catalog Number: TX10102810
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: false
• Expiration Date: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Angle: 10 degree
• Length: 28 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711TX101028100 [Primary]
HIBCC	M711TX101028101 [Package]; Contains: M711TX101028100; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180078

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-25
• Device Publish Date: 2018-08-15

On-Brand Devices [Tx™]

• M711LS4490: SST
• M711LS3960: SST, Silicone, PEEK
• M711LS3950: Al, Silicone, SST
• M711BTA152010: Polypropylene White, Radel Gray, Press-Fit W/SS
• M711BTA1510: Al, SST, Silicone
• M711BTA1500: Al, SST, Silicone
• M711BTA1490: Al, SST, Silicone
• M711BTA1550: Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
• M711BTA1540: Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
• M711BTA153030: Polypropylene White, Radel Gray, Press-Fit W/SS
• M711BTA153020: Polypropylene White, Radel Gray, Press-Fit W/SS
• M711BTA153010: Polypropylene White, Radel Gray, Press-Fit W/SS
• M711BTA152030: Polypropylene White, Radel Gray, Press-Fit W/SS
• M711BTA152020: Polypropylene White, Radel Gray, Press-Fit W/SS
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• M711TX101228101: HA PEEK, Ta
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• M711TX101128101: HA PEEK, Ta
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• M711TX100828101: HA PEEK, Ta
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• M711TX121633051: HA PEEK, Ta
• M711TX121533121: HA PEEK, Ta
• M711TX121533101: HA PEEK, Ta
• M711TX121533051: HA PEEK, Ta
• M711TX121433121: HA PEEK, Ta
• M711TX121433101: HA PEEK, Ta
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• M711TX121333121: HA PEEK, Ta
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• M711TX121233101: HA PEEK, Ta
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• M711TX121133121: HA PEEK, Ta
• M711TX121133101: HA PEEK, Ta
• M711TX121133051: HA PEEK, Ta