4CIS® Chiron Spinal Fixation System 4125-80B5

GUDID 08800033318866

4CIS® Chiron Mono Axial Screw Ø8.0 X 115mm (Rod Ø6.0)

SOLCO BIOMEDICAL CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800033318866
• NIH Device Record Key: d61464c9-ee3b-4a40-b2d6-029b4a0e5899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® Chiron Spinal Fixation System
• Version Model Number: 4125-80B5
• Catalog Number: 4125-80B5
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL 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	08800033318866 [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

[08800033318866]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

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

• 08800033335054: Sharp Tip Straight Rod Ø5.5X30mm
• 08800033305064: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.5 X 35mm (Rod Ø5.5)
• 08800033305057: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.5 X 30mm (Rod Ø5.5)
• 08800033305040: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.5 X 25mm (Rod Ø5.5)
• 08800033305033: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.5 X 20mm (Rod Ø5.5)
• 08800033305026: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 150mm (Rod Ø5.5)
• 08800033305019: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 145mm (Rod Ø5.5)
• 08800033305002: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 140mm (Rod Ø5.5)
• 08800033304999: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 135mm (Rod Ø5.5)
• 08800033304982: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 130mm (Rod Ø5.5)
• 08800033304975: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 125mm (Rod Ø5.5)
• 08800033304968: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 120mm (Rod Ø5.5)
• 08800033304951: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 115mm (Rod Ø5.5)
• 08800033304944: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 110mm (Rod Ø5.5)
• 08800033304937: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 105mm (Rod Ø5.5)
• 08800033304920: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 100mm (Rod Ø5.5)
• 08800033304913: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 95mm (Rod Ø5.5)
• 08800033304906: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 90mm (Rod Ø5.5)
• 08800033304890: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 85mm (Rod Ø5.5)
• 08800033304883: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 80mm (Rod Ø5.5)
• 08800033304876: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 75mm (Rod Ø5.5)
• 08800033304869: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 70mm (Rod Ø5.5)
• 08800033304852: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 65mm (Rod Ø5.5)
• 08800033304845: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 60mm (Rod Ø5.5)
• 08800033304838: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 55mm (Rod Ø5.5)
• 08800033304821: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 50mm (Rod Ø5.5)
• 08800033304814: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 45mm (Rod Ø5.5)
• 08800033304807: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 40mm (Rod Ø5.5)
• 08800033304791: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 35mm (Rod Ø5.5)
• 08800033304784: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 30mm (Rod Ø5.5)
• 08800033304777: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 25mm (Rod Ø5.5)
• 08800033304760: 4CIS® Chiron Mono Axial Cannulated Screw Ø8.0 X 20mm (Rod Ø5.5)
• 08800033304753: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 150mm (Rod Ø5.5)
• 08800033304746: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 145mm (Rod Ø5.5)
• 08800033304739: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 140mm (Rod Ø5.5)
• 08800033304722: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 135mm (Rod Ø5.5)
• 08800033304715: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 130mm (Rod Ø5.5)
• 08800033304708: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 125mm (Rod Ø5.5)
• 08800033304692: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 120mm (Rod Ø5.5)
• 08800033304685: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 115mm (Rod Ø5.5)
• 08800033304678: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 110mm (Rod Ø5.5)
• 08800033304661: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 105mm (Rod Ø5.5)
• 08800033304654: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 100mm (Rod Ø5.5)
• 08800033304647: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 95mm (Rod Ø5.5)
• 08800033304630: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 90mm (Rod Ø5.5)
• 08800033304623: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 85mm (Rod Ø5.5)
• 08800033304616: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 80mm (Rod Ø5.5)
• 08800033304609: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 75mm (Rod Ø5.5)
• 08800033304593: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 70mm (Rod Ø5.5)
• 08800033304586: 4CIS® Chiron Mono Axial Cannulated Screw Ø7.5 X 65mm (Rod Ø5.5)