Arristos

GUDID 00843672100391

Polyax def screw 5.5x30mm for 5.5 rod

INGENIUMSPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00843672100391
• NIH Device Record Key: 1c939ee3-9c1d-412c-9065-52182c865471
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arristos
• Version Model Number: 55025530
• Company DUNS: 082805471
• Company Name: INGENIUMSPINE, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843672100391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173126

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00843672100391]

Moist Heat or Steam Sterilization

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[00843672100391]

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[00843672100391]

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[00843672100391]

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[00843672100391]

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[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

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[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

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[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

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[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

[00843672100391]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-15

On-Brand Devices [Arristos]

• 00084372100216: Polyax screw 6.5x45mm for 5.5 rod
• 00084372100070: Polyax screw 5.5x35mm for 5.5 rod
• 00084372100063: Polyax screw 5.5x30mm for 5.5 rod
• 00083672101565: Rod Approximator
• 00843672101589: Hook Approximator 5.0 Rod
• 00843672101572: Hook Approximator 6.0mm Rod
• 00843672101558: Tap for 7.5mm Screw
• 00843672101541: Tap for 6.5mm Screw
• 00843672101534: Tap for 7.0mm Screw
• 00843672101527: Tap for 6.0mm Screw
• 00843672101510: Tap for 5.5mm Screw
• 00843672101503: 56010017
• 00843672101497: Center plug T-20 M6xH3mm
• 00843672101480: Transverse plug T-20 M6xH4mm
• 00843672101473: Buttress plug M10 T25 hooks
• 00843672101466: Buttress plug M8 T25 hooks
• 00843672101459: Smooth rod 6x500mm Ti
• 00843672101442: Smooth rod 6x500mm CrCo
• 00843672101435: Smooth rod 6x450mm
• 00843672101428: Smooth rod 6x300mm
• 00843672101411: Smooth rod 6x200mm
• 00843672101404: Smooth rod 6x180mm
• 00843672101398: Smooth rod 6x150mm
• 00843672101381: Smooth rod 6x120mm
• 00843672101374: Smooth rod 6x100mm
• 00843672101367: Smooth rod 6x90mm
• 00843672101350: Smooth rod 6x80mm
• 00843672101343: Smooth rod 6x70mm
• 00843672101336: Smooth rod 6x60mm
• 00843672101329: Smooth rod 6x50mm
• 00843672101312: Smooth rod 6x40mm
• 00843672101305: Transverse 6.0mm/71-115mm
• 00843672101299: Transverse 6.0mm/49-71mm
• 00843672101282: Transverse 6.0mm/38-49mm
• 00843672101275: Transverse 6.0mm/33-38mm
• 00843672101268: Transverse 6.0mm/30-33mm
• 00843672101251: Transverse 6.0mm/27-30mm
• 00843672101244: Polyax screw 7.5x55mm for 6.0 rod
• 00843672101237: Polyax screw 7.5x50mm for 6.0 rod
• 00843672101220: Polyax screw 7.5x45mm for 6.0 rod
• 00843672101213: Polyax screw 7.5x40mm for 6.0 rod
• 00843672101206: Polyax screw 6.5x55mm for 6.0 rod
• 00843672101190: Polyax screw 6.5x50mm for 6.0 rod
• 00843672101183: Polyax screw 6.5x45mm for 6.0 rod
• 00843672101176: Polyax screw 6.5x40mm for 6.0 rod
• 00843672101169: Polyax screw 6.5x35mm for 6.0 rod
• 00843672101152: Polyax screw 6.5x30mm for 6.0 rod
• 00843672101145: Polyax screw 5.5x55mm for 6.0 rod
• 00843672101138: Polyax screw 5.5x50mm for 6.0 rod
• 00843672101121: Polyax screw 5.5x45mm for 6.0 rod