AnyPlus® Cervical PEEK Cage System GS138-8300

GUDID 08809695610370

Kerriosn Rongeure, 3mm

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809695610370
• NIH Device Record Key: 51d794ef-5352-427f-ad21-92aa13c433fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyPlus® Cervical PEEK Cage System
• Version Model Number: GS138-8300
• Catalog Number: GS138-8300
• 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	08809695610370 [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

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

Moist Heat or Steam Sterilization

[08809695610370]

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

On-Brand Devices [AnyPlus® Cervical PEEK Cage System]

• 08809885799816: AnyPlus Persuader
• 08809695610400: Rongure 4mm, Up-Angle
• 08809695610394: Rongure 4mm, Straight
• 08809695610387: Kerriosn Rongeure, 5mm
• 08809695610370: Kerriosn Rongeure, 3mm
• 08800104077395: Shaver
• 08800104077388: Shaver
• 08800104077371: Shaver
• 08800104077364: Shaver