Indus®

GUDID 00190361001997

Invue, Cervical Plate, Four Level, 97mm

SPINEFRONTIER, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190361001997
• NIH Device Record Key: 78162f6f-8006-4254-8f94-607b0248df26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indus®
• Version Model Number: IM71045-08
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, 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: 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(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Length: 97 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter
• Width: 16.5 Millimeter
• Length: 97 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361001997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093776

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

Moist Heat or Steam Sterilization

[00190361001997]

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: 2016-04-15

On-Brand Devices [Indus®]

• 00190361039525: 12mm Trial Drill Guide, Lordotic
• 00190361039518: 11mm Trial Drill Guide, Lordotic
• 00190361039501: 10mm Trial Drill Guide, Lordotic
• 00190361039495: 9mm Trial Drill Guide, Lordotic
• 00190361039488: 8mm Trial Drill Guide, Lordotic
• 00190361039471: 7mm Trial Drill Guide, Lordotic
• 00190361039464: 6mm Trial Drill Guide, Lordotic
• 00190361039457: 5mm Trial Drill Guide, Lordotic
• 00190361039440: Invue Trial Drill Guide, 12mm
• 00190361039433: Invue Trial Drill Guide, 11mm
• 00190361039426: Invue Trial Drill Guide, 10mm
• 00190361039419: Invue Trial Drill Guide, 9mm
• 00190361039402: Invue Trial Drill Guide, 8mm
• 00190361039396: Invue Trial Drill Guide, 7mm
• 00190361039389: Invue Trial Drill Guide, 6mm
• 00190361039372: Invue Trial Drill Guide, 5mm
• 00190361002130: Invue, Self Drilling Screw, Tapered, 4.2 x 16mm
• 00190361002123: Invue, Self Drilling Screw, Tapered, 4.2 x 14mm
• 00190361002116: Invue, Self Drilling Screw, Tapered, 4.2 x 12mm
• 00190361002109: Invue, Self Tapping Screw, Tapered, 4.2 x 16mm
• 00190361002093: Invue, Self Tapping Screw, Tapered, 4.2 x 14mm
• 00190361002086: Invue, Self Tapping Screw, Tapered, 4.2 x 12mm
• 00190361002079: Invue, Self Tapping Screw, 4.0 x 16mm
• 00190361002062: Invue, Self Tapping Screw, 4.0 x 14mm
• 00190361002055: Invue, Self Tapping Screw, 4.0 x 12mm
• 00190361002048: Invue, Cervical Plate, Four Level, 61mm
• 00190361002031: Invue, Cervical Plate, Four Level, 65mm
• 00190361002024: Invue, Cervical Plate, Four Level, 109mm
• 00190361002017: Invue, Cervical Plate, Four Level, 105mm
• 00190361002000: Invue, Cervical Plate, Four Level, 101mm
• 00190361001997: Invue, Cervical Plate, Four Level, 97mm
• 00190361001980: Invue, Cervical Plate, Four Level, 93mm
• 00190361001973: Invue, Cervical Plate, Four Level, 89mm
• 00190361001966: Invue, Cervical Plate, Four Level, 85mm
• 00190361001959: Invue, Cervical Plate, Four Level, 81mm
• 00190361001942: Invue, Cervical Plate, Four Level, 77mm
• 00190361001935: Invue, Cervical Plate, Four Level, 73mm
• 00190361001928: Invue, Cervical Plate, Four Level, 69mm
• 00190361001911: Invue, Cervical Plate, Three Level, 48mm
• 00190361001904: Invue, Cervical Plate, Three Level, 51mm
• 00190361001898: Invue, Cervical Plate, Three Level, 78mm
• 00190361001881: Invue, Cervical Plate, Three Level, 75mm
• 00190361001874: Invue, Cervical Plate, Three Level, 72mm
• 00190361001867: Invue, Cervical Plate, Three Level, 69mm
• 00190361001850: Invue, Cervical Plate, Three Level, 66mm
• 00190361001843: Invue, Cervical Plate, Three Level, 63mm
• 00190361001836: Invue, Cervical Plate, Three Level, 60mm
• 00190361001829: Invue, Cervical Plate, Three Level, 57mm
• 00190361001812: Invue, Cervical Plate, Three Level, 54mm
• 00190361001805: Invue, Cervical Plate, Two Level, 33mm