Kora Spinal System

GUDID 08809214542182

Reduction Polyaxial Pedicle Screw, Ø4.0mm X 30mm, Ø6.0mm Rod

Medyssey Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08809214542182
• NIH Device Record Key: c19d4ff0-7c80-4d90-a4bb-a21d7f0ae22a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kora Spinal System
• Version Model Number: MRP4030
• Company DUNS: 688211503
• Company Name: Medyssey Co., Ltd.
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809214542182 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

[08809214542182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-21
• Device Publish Date: 2023-12-13

On-Brand Devices [Kora Spinal System]

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• 08806364621064: Monoaxial Pedicle Screw, Ø9.5mm X 70mm , Ø6.0mm Rod
• 08809214542359: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod
• 08809214542342: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod
• 08809214542335: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod
• 08809214542328: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod
• 08809214542311: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod
• 08809214542304: Reduction Polyaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod
• 08809214542267: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod
• 08809214542250: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod
• 08809214542243: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod
• 08809214542236: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod
• 08809214542229: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod
• 08809214542212: Reduction Polyaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod
• 08809214542205: Reduction Polyaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod
• 08809214542199: Reduction Polyaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod
• 08809214542182: Reduction Polyaxial Pedicle Screw, Ø4.0mm X 30mm, Ø6.0mm Rod
• 08809214542175: Reduction Polyaxial Pedicle Screw, Ø4.0mm X 25mm, Ø6.0mm Rod
• 08809214542168: Reduction Polyaxial Pedicle Screw, Ø4.0mm X 20mm, Ø6.0mm Rod
• 08809214541482: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod
• 08809214541475: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod
• 08809214541468: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod
• 08809214541451: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod
• 08809214541444: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod
• 08809214541437: Reduction Monoaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod
• 08809214541390: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod
• 08809214541383: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod
• 08809214541376: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod
• 08809214541369: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod
• 08809214541352: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod
• 08809214541345: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod
• 08809214541338: Reduction Monoaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod
• 08809214541321: Reduction Monoaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod
• 08809214541314: Reduction Monoaxial Pedicle Screw, Ø4.0mm X 30mm, Ø6.0mm Rod
• 08809214541307: Reduction Monoaxial Pedicle Screw, Ø4.0mm X 25mm, Ø6.0mm Rod
• 08809214541291: Reduction Monoaxial Pedicle Screw, Ø4.0mm X 20mm, Ø6.0mm Rod
• 08806364692361: Polyaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod
• 08806364692354: Polyaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod
• 08806364692347: Polyaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod
• 08806364692330: Polyaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod
• 08806364692323: Polyaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod
• 08806364692316: Polyaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod
• 08806364692279: Polyaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod
• 08806364692262: Polyaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod
• 08806364692255: Polyaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod
• 08806364692248: Polyaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod
• 08806364692231: Polyaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod
• 08806364692224: Polyaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod
• 08806364692217: Polyaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod
• 08806364692200: Polyaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod