GSS™ and AnyPlus® GS110-1533

GUDID 08809695601781

In-Situ Bende, Right

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809695601781
• NIH Device Record Key: 702c294f-d1ab-4d7b-8ba7-f091d08c0577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSS™ and AnyPlus®
• Version Model Number: GS110-1533
• Catalog Number: GS110-1533
• 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	08809695601781 [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

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

Moist Heat or Steam Sterilization

[08809695601781]

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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• 08806395478736: Accessory Caddy
• 08806395478705: AnyPlus Deformity System Implants & Instruments Tray
• 08806395450794: Long Arm Screw Caddy
• 08806395450787: Set Screw Caddy
• 08806395450763: AnyPlus Long Arm Screw Instruments Tray
• 08806395450756: AnyPlus Long Arm Screw Implants Tray
• 08806395404285: Anyplus Standard Instruments Tray
• 08806395404278: Crosslink Caddy
• 08806395404261: Anyplus Standard Implants&Instruments Tray
• 08806395404179: Anyplus 5.5 Pedicle Screw Inetruments&Implants Tray
• 08806395404148: Accessory Caddy
• 08806395492237: Crosslink Driver 1/4" Square Chuck
• 08806395492220: Crosslink Driver Hudson Chuck
• 08806395470945: Dual Lead Tap 8.0
• 08806395470938: Dual Lead Tap 4.5
• 08806395450893: Derotator Combining Device, Large
• 08806395450886: Inner Ejector
• 08806395450879: Outer Slider
• 08806395450862: Derotator
• 08806395435333: Anyplus Dual Lead Tap
• 08806395435326: Anyplus Dual Lead Tap
• 08806395435319: Anyplus Dual Lead Tap
• 08806395403998: Crosslink Set Screw Driver
• 08806395403912: Poly Screw Head Adjuster
• 08806395403882: Anti-Torque Wrench
• 08806395403868: Distractor
• 08806395403837: Compressor
• 08806395403752: Final Driver Shaft for Crosslink III
• 08806395403660: AnyPlus Set Screw Driver shaft
• 08806395403493: Set Screw Starter I-Handle
• 08806395403486: Set Screw Starter
• 08806395403424: AnyPlus Rod Rocker
• 08806395403349: AnyPlus Kerrison Persuader
• 08806395403271: Rod Pusher
• 08806395403226: In-situ Bender, Right
• 08806395403172: In-Situ Bender, Left
• 08806395403127: French Rod Bender
• 08806395403080: Long Arm Tab Breaker
• 08806395403042: Anyplus Rod Holder
• 08806395403011: Ring Handle Rod Holder
• 08806395402953: Screw Adjuster Shaft
• 08806395402748: AnyPlus Poly Screw Driver
• 08806395402663: Poly Reduction Screw Driver Shaft
• 08806395402588: Poly Screw Driver Shaft
• 08806395402571: Poly Screw Driver Shaft
• 08806395402540: Poly Screw Driver Shaft
• 08806395402533: Poly Screw Driver Shaft
• 08806395402007: I-Ratchet Handle, Large
• 08806395401987: Tap, 8.5
• 08806395401901: Tap, 7.5