MEGA5.5 SPINE SYSTEM

GUDID 08809228126026

Pre-bent Rod, Ø5.5 x 160mm

BK MEDITECH CO.,LTD.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08809228126026
• NIH Device Record Key: e8c3daa7-f18a-4291-bae7-82f0b430e85c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGA5.5 SPINE SYSTEM
• Version Model Number: 82130-160
• 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	08809228126026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123476

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

Moist Heat or Steam Sterilization

[08809228126026]

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 [MEGA5.5 SPINE SYSTEM]

• 08809763505287: Pick Up Wrench
• 08809763505270: Final Wrench
• 08809763505263: Multi-axial Long-arm Screw Driver
• 08809763505256: Multi-axial Screw Driver
• 08809763505249: Long-arm Screw Driver
• 08809763505232: Mono Screw Driver
• 08809763505225: Rod Bender
• 08809763505218: Anti-Torque Driver
• 08809763505188: Rod Pusher
• 08809763500671: 4.5mm Tap
• 08809763500497: 7.5mm Tap
• 08809763500480: 6.5mm Tap
• 08809763500473: 5.5mm Tap
• 08809763500381: Bent Probe
• 08809763500374: Straight Probe
• 08809763500367: Awl
• 08809763505805: T-Torque Handle
• 08809763505317: Persuader
• 08809763505300: Alignment Driver
• 08809763505294: Long-Arm Breaker
• 08809763501425: Reducer
• 08809763501395: GR Reducer
• 08809763501364: SC Reducer
• 08809763500343: Wrench 4.0
• 08809228126101: Cross-Link, 55mm
• 08809228126095: Cross-Link, 50mm
• 08809228126088: Cross-Link, 45mm
• 08809228126071: Cross-Link, 40mm
• 08809228126064: Pre-bent Rod, Ø5.5 x 200mm
• 08809228126057: Pre-bent Rod, Ø5.5 x 190mm
• 08809228126040: Pre-bent Rod, Ø5.5 x 180mm
• 08809228126033: Pre-bent Rod, Ø5.5 x 170mm
• 08809228126026: Pre-bent Rod, Ø5.5 x 160mm
• 08809228126019: Pre-bent Rod, Ø5.5 x 150mm
• 08809228126002: Pre-bent Rod, Ø5.5 x 140mm
• 08809228125999: Pre-bent Rod, Ø5.5 x 130mm
• 08809228125982: Pre-bent Rod, Ø5.5 x 120mm
• 08809228125975: Pre-bent Rod, Ø5.5 x 110mm
• 08809228125968: Pre-bent Rod, Ø5.5 x 100mm
• 08809228125951: Pre-bent Rod, Ø5.5 x 90mm
• 08809228125944: Pre-bent Rod, Ø5.5 x 80mm
• 08809228125937: Pre-bent Rod, Ø5.5 x 75mm
• 08809228125920: Pre-bent Rod, Ø5.5 x 70mm
• 08809228125913: Pre-bent Rod, Ø5.5 x 65mm
• 08809228125906: Pre-bent Rod, Ø5.5 x 60mm
• 08809228125890: Pre-bent Rod, Ø5.5 x 55mm
• 08809228125883: Pre-bent Rod, Ø5.5 x 50mm
• 08809228125876: Pre-bent Rod, Ø5.5 x 45mm
• 08809228125869: Pre-bent Rod, Ø5.5 x 40mm
• 08809228125852: Pre-bent Rod, Ø5.5 x 35mm