4CIS VANE SPINE SYSTEM 4714-4535

GUDID 08800033386421

Mono Axial Pedicle Screw, 4.5x35mm

ALPHANOX CO.,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08800033386421
• NIH Device Record Key: e8a1a52f-87c5-4941-b914-97835b551fe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS VANE SPINE SYSTEM
• Version Model Number: 4714-4535
• Catalog Number: 4714-4535
• 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	08800033386421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101818

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08800033386421]

Moist Heat or Steam Sterilization

[08800033386421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2026-01-14
• Device Publish Date: 2015-09-24

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