4CIS® Chiron Spinal Fixation System 4124-7035

GUDID 08800033300748

4CIS® Chiron Mono Axial Screw Ø7.0 X 35mm (Rod Ø5.5)

ALPHANOX CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800033300748
• NIH Device Record Key: f8a6359a-007f-4d9e-8e82-0f5048008c8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® Chiron Spinal Fixation System
• Version Model Number: 4124-7035
• Catalog Number: 4124-7035
• Company DUNS: 687844241
• Company Name: ALPHANOX CO.,LTD.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800033300748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190471

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

[08800033300748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-29
• Device Publish Date: 2019-08-13

On-Brand Devices [4CIS® Chiron Spinal Fixation System]

• 08806373590320: Spinal Rigid Rod Ø6.0X110mm
• 08806373589072: CCM Rod Straight Ø5.5X100mm
• 08806373588907: 4CIS® Chiron Mono Axial Screw Ø4.0 X 20mm (Rod Ø5.5)
• 08806373588884: Spinal Rigid Rod Ø5.5X45mm
• 08806373588853: Spinal Rigid Rod Ø6.0X60mm
• 08806373588846: Spinal Rigid Rod Ø6.0X50mm
• 08806373588709: Spinal Pre-bend Rod Ø6.0X50mm
• 08806373588693: Spinal Pre-bend Rod Ø6.0X45mm
• 08806373588686: Spinal Rigid Rod Ø6.0X70mm
• 08806373588679: Spinal Rigid Rod Ø6.0X130mm
• 08806373588594: 4CIS® Chiron Poly Axial Cannulated Screw Ø6.5 X 45mm (Rod Ø5.5)
• 08806373588532: Spinal Rigid Rod Ø5.5X25mm
• 08806373588525: Spinal Rigid Rod Ø5.5X60mm
• 08806373585982: Spinal Rigid Rod Ø5.5X100mm
• 08806373583766: 4CIS® Chiron Nut
• 08806373571732: Spinal Rigid Rod Ø6.0X600mm
• 08806373570636: Spinal Rigid Rod Ø6.0X400mm
• 08800033335658: CCM Rod Straight Ø5.5X600mm
• 08800033335641: CCM Rod Straight Ø5.5X550mm
• 08800033335634: CCM Rod Straight Ø5.5X500mm
• 08800033335627: CCM Rod Straight Ø5.5X450mm
• 08800033335610: CCM Rod Straight Ø5.5X400mm
• 08800033335603: CCM Rod Straight Ø5.5X350mm
• 08800033335597: CCM Rod Straight Ø5.5X300mm
• 08800033335580: CCM Rod Straight Ø5.5X250mm
• 08800033335573: CCM Rod Straight Ø5.5X200mm
• 08800033335566: CCM Rod Straight Ø5.5X190mm
• 08800033335559: CCM Rod Straight Ø5.5X180mm
• 08800033335542: CCM Rod Straight Ø5.5X170mm
• 08800033335535: CCM Rod Straight Ø5.5X160mm
• 08800033335528: CCM Rod Straight Ø5.5X150mm
• 08800033335511: CCM Rod Straight Ø5.5X140mm
• 08800033335504: CCM Rod Straight Ø5.5X130mm
• 08800033335498: CCM Rod Straight Ø5.5X120mm
• 08800033335481: CCM Rod Straight Ø5.5X110mm
• 08800033335474: CCM Rod Straight Ø5.5X95mm
• 08800033335467: CCM Rod Straight Ø5.5X90mm
• 08800033335450: CCM Rod Straight Ø5.5X85mm
• 08800033335443: CCM Rod Straight Ø5.5X80mm
• 08800033335436: CCM Rod Straight Ø5.5X75mm
• 08800033335429: CCM Rod Straight Ø5.5X70mm
• 08800033335412: CCM Rod Straight Ø5.5X65mm
• 08800033335405: CCM Rod Straight Ø5.5X60mm
• 08800033335399: CCM Rod Straight Ø5.5X55mm
• 08800033335382: CCM Rod Straight Ø5.5X50mm
• 08800033335375: CCM Rod Straight Ø5.5X45mm
• 08800033335368: CCM Rod Straight Ø5.5X40mm
• 08800033335351: CCM Rod Straight Ø5.5X35mm
• 08800033335344: CCM Rod Straight Ø5.5X30mm
• 08800033335337: Sharp Tip Straight Rod Ø5.5X400mm