Ax®

GUDID M711LS3880

Al, Silicone, SST

Innovasis, Inc.

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• Primary Device ID: M711LS3880
• NIH Device Record Key: 036a5549-a290-4063-8f5c-e0ac7ce25453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ax®
• Version Model Number: LS-388
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS3880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182139

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

[M711LS3880]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [Ax®]

• M711LS4480: SST
• M711LS3940: SST
• M711LS3560: Al, Silicone, SST
• M711LS3210: SST
• M711LS3130: Al, Silicone, Radel, SST
• M711LS3120: Al, Silicone, SST
• M711LS3090: SST
• M711LS3880: Al, Silicone, SST
• M711BTA1250: Polypropylene, Radel, SST
• M711BTA1200: Al, Nylon, Silicone
• M711BTA1210: Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
• M711BTA1240: Al, Nylon, Silicone
• M711BTA1230: Al, Nylon, Silicone
• M711BTA1460: Al, SST, Silicone
• M711BTA1440: Al, SST, Silicone
• M711BTA1430: Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
• M711LS3360: Anterior Cup Curette, Straight, Size 4, Al, Silicone, SST
• M711LS3350: Anterior Cup Curette, Straight, Size 2, Al, Silicone, SST
• M711LS3340: Anterior Cup Curette, Angled Up, Size 4, Al, Silicone, SST
• M711LS3330: Anterior Cup Curette, Angled Up, Size 2, Al, Silicone, SST
• M711LS3320: Anterior Triangle Curette, Double Sided, 11mm, Al, Silicone, SST
• M711LS3310: Anterior, Angled, Ring Curette, Double Sided, 9mm, Al, Silicone, SST