4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM 5932-1122

GUDID 08806373580758

4CIS® Pinehurst Drill Guide-Variable

ALPHANOX CO.,LTD.

External spinal fixation system

• Primary Device ID: 08806373580758
• NIH Device Record Key: 655a3ae0-6d44-4511-9c3e-b53b89e1d4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM
• Version Model Number: 5932-1122
• Catalog Number: 5932-1122
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373580758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182489

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

Moist Heat or Steam Sterilization

[08806373580758]

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: 2019-01-24

On-Brand Devices [4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM]

• 08806373581472: 4CIS® Pinehurst Plate Holder
• 08806373581229: 4CIS® Pinehurst Single DTS
• 08806373581212: 4CIS® Pinehurst Double DTS
• 08806373580895: 4CIS® Pinehurst Drill 16mm
• 08806373580888: 4CIS® Pinehurst Drill 14mm
• 08806373580871: 4CIS® Pinehurst Drill 12mm
• 08806373580864: 4CIS® Pinehurst Drill 10mm
• 08806373580840: 4CIS® Pinehurst Plate Bender
• 08806373580796: 4CIS® Pinehurst Self Constrained Awl
• 08806373580789: 4CIS® Pinehurst Hexlobe Screw Removal Tool
• 08806373580772: 4CIS® Pinehurst Temporary Fixation Pin Inserter
• 08806373580765: 4CIS® Pinehurst Screw Driver
• 08806373580758: 4CIS® Pinehurst Drill Guide-Variable
• 08806373580741: 4CIS® Pinehurst Drill Guide-Fixed
• 08806373580727: 4CIS® Pinehurst Tap 10mm