4CIS APOLLON SPINE SYSTEM 4901-3014

GUDID 08806373526176

Rod Insertion Set

SOLCO BIOMEDICAL CO.,LTD.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08806373526176
• NIH Device Record Key: 056d87ba-7717-4dcb-967e-d075503ce424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS APOLLON SPINE SYSTEM
• Version Model Number: 4901-3014
• Catalog Number: 4901-3014
• 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: 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	08806373526176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082453

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08806373526176]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-20

On-Brand Devices [4CIS APOLLON SPINE SYSTEM]

• 08806373556333: Apollon Screw Outer Holder
• 08806373550560: Apollon Holder Connector
• 08806373545092: Apollon Screw Inner Holder
• 08806373526176: Rod Insertion Set