Idys®-LLIF 3DTi 51725090

GUDID 03700780635382

LLIF TRIAL

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780635382
• NIH Device Record Key: ab786477-9ce5-4651-8a7c-605b0cedb1e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®-LLIF 3DTi
• Version Model Number: 51725090
• Catalog Number: 51725090
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter
• Angle: 0 degree
• Width: 25 Millimeter
• Height: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780635382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202032

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

[03700780635382]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [Idys®-LLIF 3DTi]

• 03700780634538: LLIF 3DTi Plate
• 03700780634521: LLIF 3DTi Plate
• 03700780634514: LLIF 3DTi Plate
• 03700780634507: LLIF 3DTi Plate
• 03700780634491: LLIF 3DTi Plate
• 03700780634309: LLIF 3DTi Cage
• 03700780634293: LLIF 3DTi Cage
• 03700780634286: LLIF 3DTi Cage
• 03700780634279: LLIF 3DTi Cage
• 03700780634262: LLIF 3DTi Cage
• 03700780634255: LLIF 3DTi Cage
• 03700780634248: LLIF 3DTi Cage
• 03700780634231: LLIF 3DTi Cage
• 03700780634224: LLIF 3DTi Cage
• 03700780634217: LLIF 3DTi Cage
• 03700780634200: LLIF 3DTi Cage
• 03700780634194: LLIF 3DTi Cage
• 03700780634187: LLIF 3DTi Cage
• 03700780634170: LLIF 3DTi Cage
• 03700780634163: LLIF 3DTi Cage
• 03700780634156: LLIF 3DTi Cage
• 03700780634149: LLIF 3DTi Cage
• 03700780634132: LLIF 3DTi Cage
• 03700780634125: LLIF 3DTi Cage
• 03700780634118: LLIF 3DTi Cage
• 03700780634101: LLIF 3DTi Cage
• 03700780634095: LLIF 3DTi Cage
• 03700780634088: LLIF 3DTi Cage
• 03700780634071: LLIF 3DTi Cage
• 03700780634064: LLIF 3DTi Cage
• 03700780634057: LLIF 3DTi Cage
• 03700780634040: LLIF 3DTi Cage
• 03700780634033: LLIF 3DTi Cage
• 03700780634026: LLIF 3DTi Cage
• 03700780634019: LLIF 3DTi Cage
• 03700780634002: LLIF 3DTi Cage
• 03700780633999: LLIF 3DTi Cage
• 03700780633975: LLIF 3DTi Cage
• 03700780633968: LLIF 3DTi Cage
• 03700780633951: LLIF 3DTi Cage
• 03700780633944: LLIF 3DTi Cage
• 03700780633937: LLIF 3DTi Cage
• 03700780633920: LLIF 3DTi Cage
• 03700780633913: LLIF 3DTi Cage
• 03700780633906: LLIF 3DTi Cage
• 03700780633890: LLIF 3DTi Cage
• 03700780633883: LLIF 3DTi Cage
• 03700780633876: LLIF 3DTi Cage
• 03700780633869: LLIF 3DTi Cage
• 03700780633852: LLIF 3DTi Cage