AccelFix Spinal Fixation System 8112-5025

GUDID 08800061309195

Reduction Mono Axial Screw Ø5.0 , 25mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800061309195
• NIH Device Record Key: 7ff7235f-7645-4b67-9042-4e8340687ef8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Spinal Fixation System
• Version Model Number: 8112-5025
• Catalog Number: 8112-5025
• Company DUNS: 631159324
• Company Name: L&K BIOMED 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	08800061309195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182544

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

[08800061309195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [AccelFix Spinal Fixation System]

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• 08800061302424: Reduction Mono Axial Screw Ø6.5 , 105mm
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• 08800061302387: Reduction Mono Axial Screw Ø6.5 , 85mm
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• 08800061302363: Reduction Mono Axial Screw Ø6.5 , 75mm
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• 08800061302349: Reduction Mono Axial Screw Ø6.5 , 65mm
• 08800061302332: Reduction Mono Axial Screw Ø6.5 , 60mm
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• 08800061302943: Reduction Mono Axial Screw Ø7.5 , 95mm
• 08800061302936: Reduction Mono Axial Screw Ø7.5 , 90mm
• 08800061302929: Reduction Mono Axial Screw Ø7.5 , 85mm
• 08800061302912: Reduction Mono Axial Screw Ø7.5 , 80mm
• 08800061302905: Reduction Mono Axial Screw Ø7.5 , 75mm
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• 08800061302851: Reduction Mono Axial Screw Ø7.5 , 50mm
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• 08800061302837: Reduction Mono Axial Screw Ø7.5 , 40mm
• 08800061302820: Reduction Mono Axial Screw Ø7.5 , 35mm
• 08800061302813: Reduction Mono Axial Screw Ø7.5 , 30mm
• 08800061302806: Reduction Mono Axial Screw Ø7.5 , 25mm
• 08800061302790: Reduction Mono Axial Screw Ø7.5 , 20mm
• 08800061302783: Reduction Mono Axial Screw Ø7.0 , 150mm
• 08800061302776: Reduction Mono Axial Screw Ø7.0 , 145mm
• 08800061302769: Reduction Mono Axial Screw Ø7.0 , 140mm
• 08800061302752: Reduction Mono Axial Screw Ø7.0 , 135mm
• 08800061302745: Reduction Mono Axial Screw Ø7.0 , 130mm
• 08800061302738: Reduction Mono Axial Screw Ø7.0 , 125mm
• 08800061302721: Reduction Mono Axial Screw Ø7.0 , 120mm
• 08800061302714: Reduction Mono Axial Screw Ø7.0 , 115mm
• 08800061302707: Reduction Mono Axial Screw Ø7.0 , 110mm
• 08800061302691: Reduction Mono Axial Screw Ø7.0 , 105mm
• 08800061302684: Reduction Mono Axial Screw Ø7.0 , 100mm
• 08800061302677: Reduction Mono Axial Screw Ø7.0 , 95mm
• 08800061302660: Reduction Mono Axial Screw Ø7.0 , 90mm
• 08800061302653: Reduction Mono Axial Screw Ø7.0 , 85mm