AnyPlus Spinal Fixation System 1309-0002

GUDID 08806395490813

The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. The components are manufactured from Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

GS Medical Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806395490813
• NIH Device Record Key: 84887131-8f2b-41b7-a8ae-83b986c11245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyPlus Spinal Fixation System
• Version Model Number: 1309-0002
• Catalog Number: 1309-0002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806395490813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091717

FDA Product Code

• NBK: System,Test,(Ihc),Tumor Marker,Monitoring,Bladder Cancer

Sterilization

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

[08806395490813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [AnyPlus Spinal Fixation System]

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