MEGA SPINE SYSTEM

GUDID 08809155856096

Mono Screw, Ø5.5 x 45mm

BK MEDITECH CO.,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08809155856096
• NIH Device Record Key: bdab1ee0-e097-45c4-9968-eed48e4b9461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGA SPINE SYSTEM
• Version Model Number: 61155-45
• Company DUNS: 687941818
• Company Name: BK MEDITECH 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809155856096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072436

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

[08809155856096]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-26
• Device Publish Date: 2015-09-22

On-Brand Devices [MEGA SPINE SYSTEM]

• 08809763500282: Anti-Torque Driver
• 08809763500251: T-Wrench 3.0mm
• 08809763500244: T-Wrench 5.0mm (Short)
• 08809763500237: T-Wrench 5.0mm (Long)
• 08809763500220: Multi Screw Driver
• 08809763500213: Long arm Screw Driver
• 08809763500206: Mono Screw Driver
• 08809763500183: Rod Introducer
• 08809763500114: Guide Pin
• 08809763500107: Guide Pin
• 08809763501890: Locking Bolt Sleeve
• 08809763501586: Torque Limiting Wrench 3.0mm
• 08809763501456: Anti-Torque
• 08809763501432: Reducer
• 08809763501388: GR Reducer
• 08809763501357: SC Reducer
• 08809763501319: Multi-Axial Screw Driver
• 08809763501302: Long-Arm Screw Driver
• 08809763501296: Mono Screw Driver
• 08809763501050: Rod Reducer
• 08809763501043: Anti-Torque Driver
• 08809763501029: Pick-Up Wrench
• 08809763501012: Multi Screw Driver
• 08809763501005: Long-Arm Screw Driver
• 08809763500992: Mono Screw Driver
• 08809763500985: Long-Arm Breaker
• 08809763500978: Distractor
• 08809763500961: Compressor
• 08809763500947: Awl
• 08809763500923: Long-Arm Breaker
• 08809763500916: Derotator
• 08809763500909: Long-Arm Reduction Introducer
• 08809763500787: Final Wrench(5mm)
• 08809763500756: Multi Screw Driver
• 08809763500749: Long-Arm Screw Driver
• 08809763500732: Mono Screw Driver
• 08809763500718: Bent Probe
• 08809763500701: Straight Probe
• 08809763500695: Awl
• 08809763500664: T-Wrench 3.0mm
• 08809763500657: Final Wrench(5mm)
• 08809763500640: Pick-Up Wrench
• 08809763500572: Multi Screw Driver
• 08809763500565: Long-Arm Screw Driver
• 08809763500558: Mono Screw Driver
• 08809763500534: French Rod Bender
• 08809763500527: Rod Rocker
• 08809763500510: Reduction Introducer
• 08809763500503: Alignment Driver
• 08809763500411: Rod Pusher