AnyPlus Cervical PEEK Cage System 1182-5409

GUDID 08806378344812

The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage device is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage is designed for interbody stabilization of the cervical spine.

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08806378344812
• NIH Device Record Key: 88cc8864-73ea-4fba-a339-95aafc6f0b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyPlus Cervical PEEK Cage System
• Version Model Number: 1182-5409
• Catalog Number: 1182-5409
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806378344812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153517

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08806378344812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-08-30

On-Brand Devices [AnyPlus Cervical PEEK Cage System]

• 08806395435838: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435821: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435814: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435807: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435791: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435784: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435777: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435760: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435692: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435685: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435678: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435661: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435654: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395435647: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395424986: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806395424979: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344843: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344836: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344829: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344812: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344805: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344799: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344782: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806378344775: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106497: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106480: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106473: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106466: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106459: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106442: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106435: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i
• 08806162106428: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the i