MEGA PLUS SPINE SYSTEM

GUDID 08809493856062

Long-Arm Multi-axial Screw, Ø9.5 x 65mm, Ø6.0mm Rod

BK MEDITECH CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08809493856062
• NIH Device Record Key: 0fa3c64f-0dd6-479c-943b-930de5e5d2f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGA PLUS SPINE SYSTEM
• Version Model Number: 93295-65
• 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	08809493856062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173180

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08809493856062]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-07
• Device Publish Date: 2019-12-30

On-Brand Devices [MEGA PLUS SPINE SYSTEM]

• 08809665582249: LED Rod, Ø5.5 x 70-140mm
• 08809665582232: LED Rod, Ø5.5 x 70-70mm
• 08809665582225: LED Rod, Ø5.5 x 40-70mm
• 08809665582218: LED Rod, Ø5.5 x 40-40mm
• 08809665582201: LED Rod, Ø6.0 x 70-140mm
• 08809665582195: LED Rod, Ø6.0 x 70-70mm
• 08809665582188: LED Rod, Ø6.0 x 40-70mm
• 08809665582171: LED Rod, Ø6.0 x 40-40mm
• 08809665582164: Deformity Hex Rod(CoCr), Ø5.5 x 500mm
• 08809665582157: Deformity Hex Rod(CoCr), Ø5.5 x 400mm
• 08809665582140: Deformity Hex Rod(CoCr), Ø5.5 x 300mm
• 08809665582133: Deformity Hex Rod(CoCr), Ø6.0 x 500mm
• 08809665582126: Deformity Hex Rod(CoCr), Ø6.0 x 400mm
• 08809665582119: Deformity Hex Rod(CoCr), Ø6.0 x 300mm
• 08809665582102: Deformity Rod(CoCr), Ø5.5 x 500mm
• 08809665582096: Deformity Rod(CoCr), Ø5.5 x 400mm
• 08809665582089: Deformity Rod(CoCr), Ø5.5 x 300mm
• 08809665582072: Deformity Rod(CoCr), Ø6.0 x 500mm
• 08809665582065: Deformity Rod(CoCr), Ø6.0 x 400mm
• 08809665582058: Deformity Rod(CoCr), Ø6.0 x 300mm
• 08809665582041: Pre-bent Hex Rod(CoCr), Ø5.5 x 200mm
• 08809665582034: Pre-bent Hex Rod(CoCr), Ø5.5 x 190mm
• 08809665582027: Pre-bent Hex Rod(CoCr), Ø5.5 x 180mm
• 08809665582010: Pre-bent Hex Rod(CoCr), Ø5.5 x 170mm
• 08809665582003: Pre-bent Hex Rod(CoCr), Ø5.5 x 160mm
• 08809665581990: Pre-bent Hex Rod(CoCr), Ø5.5 x 150mm
• 08809665581983: Pre-bent Hex Rod(CoCr), Ø5.5 x 140mm
• 08809665581976: Pre-bent Hex Rod(CoCr), Ø5.5 x 130mm
• 08809665581969: Pre-bent Hex Rod(CoCr), Ø5.5 x 120mm
• 08809665581952: Pre-bent Hex Rod(CoCr), Ø5.5 x 110mm
• 08809665581945: Pre-bent Hex Rod(CoCr), Ø5.5 x 100mm
• 08809665581938: Pre-bent Hex Rod(CoCr), Ø5.5 x 90mm
• 08809665581921: Pre-bent Hex Rod(CoCr), Ø5.5 x 80mm
• 08809665581914: Pre-bent Hex Rod(CoCr), Ø5.5 x 75mm
• 08809665581907: Pre-bent Hex Rod(CoCr), Ø5.5 x 70mm
• 08809665581891: Pre-bent Hex Rod(CoCr), Ø5.5 x 65mm
• 08809665581884: Pre-bent Hex Rod(CoCr), Ø5.5 x 60mm
• 08809665581877: Pre-bent Hex Rod(CoCr), Ø5.5 x 55mm
• 08809665581860: Pre-bent Hex Rod(CoCr), Ø5.5 x 50mm
• 08809665581853: Pre-bent Hex Rod(CoCr), Ø5.5 x 45mm
• 08809665581846: Pre-bent Hex Rod(CoCr), Ø5.5 x 40mm
• 08809665581839: Pre-bent Hex Rod(CoCr), Ø5.5 x 35mm
• 08809665581822: Pre-bent Hex Rod(CoCr), Ø5.5 x 30mm
• 08809665581815: Pre-bent Hex Rod(CoCr), Ø6.0 x 200mm
• 08809665581808: Pre-bent Hex Rod(CoCr), Ø6.0 x 190mm
• 08809665581792: Pre-bent Hex Rod(CoCr), Ø6.0 x 180mm
• 08809665581785: Pre-bent Hex Rod(CoCr), Ø6.0 x 170mm
• 08809665581778: Pre-bent Hex Rod(CoCr), Ø6.0 x 160mm
• 08809665581761: Pre-bent Hex Rod(CoCr), Ø6.0 x 150mm
• 08809665581754: Pre-bent Hex Rod(CoCr), Ø6.0 x 140mm