Anyplus ll Spinal Fixation System GS110-5061

GUDID 08809974799819

DL Nav Compatible Tap Ø7.5

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809974799819
• NIH Device Record Key: ab05fac2-b28f-4da1-833f-77ba4d5cd6de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anyplus ll Spinal Fixation System
• Version Model Number: GS110-5061
• Catalog Number: GS110-5061
• 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	08809974799819 [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

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

[08809974799819]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-11
• Device Publish Date: 2025-04-03

On-Brand Devices [Anyplus ll Spinal Fixation System]

• 08809974799826: DL Nav Compatible Tap Ø8.5
• 08809974799819: DL Nav Compatible Tap Ø7.5
• 08809974799802: DL Nav Compatible Tap Ø6.5
• 08809974799796: DL Nav Compatible Tap Ø5.5