AnyPlus® Cervical PEEK Cage System GS138-5232

GUDID 08800104077388

Shaver

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800104077388
• NIH Device Record Key: 7c89dd24-13e3-4533-b766-6ce0a0132b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyPlus® Cervical PEEK Cage System
• Version Model Number: GS138-5232
• Catalog Number: GS138-5232
• Company DUNS: 688385418
• Company Name: GS Medical Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800104077388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100516

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

[08800104077388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

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• 08800104077395: Shaver
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