LumFix Spinal Fixation System

GUDID 08809658601865

Regulation Name: Pedicle screw spinal system

CG Bio Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08809658601865
• NIH Device Record Key: 431f0207-5f29-46ea-8c69-4d2acda7c255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumFix Spinal Fixation System
• Version Model Number: RDPS5550
• Company DUNS: 631130655
• Company Name: CG Bio 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	08809658601865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160731

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08809658601865]

Dry Heat Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

[08809658601865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [LumFix Spinal Fixation System]

• 08809658602039: Regulation Name: Pedicle screw spinal system
• 08809658602022: Regulation Name: Pedicle screw spinal system
• 08809658602015: Regulation Name: Pedicle screw spinal system
• 08809658602008: Regulation Name: Pedicle screw spinal system
• 08809658601995: Regulation Name: Pedicle screw spinal system
• 08809658601988: Regulation Name: Pedicle screw spinal system
• 08809658601971: Regulation Name: Pedicle screw spinal system
• 08809658601964: Regulation Name: Pedicle screw spinal system
• 08809658601957: Regulation Name: Pedicle screw spinal system
• 08809658601940: Regulation Name: Pedicle screw spinal system
• 08809658601933: Regulation Name: Pedicle screw spinal system
• 08809658601926: Regulation Name: Pedicle screw spinal system
• 08809658601919: Regulation Name: Pedicel screw spinal system
• 08809658601902: Regulation Name: Pedicel screw spinal system
• 08809658601896: Regulation Name: Pedicle screw spinal system
• 08809658601889: Regulation Name: Pedcile screw spinal system
• 08809658601872: Regulation Name: Pedicle screw spinal system
• 08809658601865: Regulation Name: Pedicle screw spinal system
• 08809658601858: Regulation Name: Pedicle screw spinal system
• 08809658601841: Regulation Name: Pedicle screw spinal system
• 08809658601834: Regulation Name: Pedicle screw spinal system
• 08809658601827: Regulation Name: Pedicle screw spinal system
• 08809658601810: Regulation Name: Pedicle screw spinal system
• 08809658601803: Regulation Name: Pedicle screw spinal system
• 08809550978461: Regulation Name: Pedicle screw spinal system
• 08809429619099: Regulation Name: Pedicle screw spinal system
• 08809429618757: Regulation Name: Pedicle screw spinal system
• 08809429618740: Regulation Name: Pedicle screw spinal system
• 08809429618733: Regulation Name: Pedicle screw spinal system
• 08809429614872: Regulation Name: Pedicle screw spinal system
• 08809429614841: Regulation Name: Pedicle screw spinal system
• 08809429614834: Regulation Name: Pedicle screw spinal system
• 08809429611130: Regulation Name: Pedicle screw spinal system
• 08809429611031: Regulation Name: Pedicle screw spinal system
• 08809429611024: Regulation Name: Pedicle screw spinal system
• 08809429611017: Regulation Name: Pedicle screw spinal system
• 08809429610904: Regulation Name: Pedicle screw spinal system
• 08809304757007: Regulation Name: Pedicle screw spinal system
• 08809304756994: Regulation Name: Pedicle screw spinal system
• 08809304756987: Regulation Name: Pedicle screw spinal system
• 08809429619341: Regulation Name: Pedicle screw spinal system
• 08809429619334: Regulation Name: Pedicle screw spinal system
• 08809429619327: Regulation Name: Pedicle screw spinal system
• 08809429619310: Regulation Name: Pedicle screw spinal system
• 08809429619303: Regulation Name: Pedicle screw spinal system
• 08809429619242: Regulation Name: Pedicle screw spinal system
• 08809429619235: Regulation Name: Pedicle screw spinal system
• 08809429619228: Regulation Name: Pedicle screw spinal system
• 08809429619211: Regulation Name: Pedicle screw spinal system
• 08809429619204: Regulation Name: Pedicle screw spinal system