Medyssey Spinal System - Rod

GUDID 08800042402747

Z-Shaped Pre-bending Rod, Ø5.5mm to Ø6.0mm, 160mm Length

Medyssey Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800042402747
• NIH Device Record Key: 262f6183-9365-4dd3-975b-694c827ae4cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medyssey Spinal System - Rod
• Version Model Number: ZR55160A
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	08800042402747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181978

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

[08800042402747]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-19
• Device Publish Date: 2018-10-25

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