AccelFix Spinal Fixation System Instrument Set LS05-0024

GUDID 08809986460554

Basic Lower Tray

L&K BIOMED CO. ,LTD.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08809986460554
• NIH Device Record Key: ba7accc8-ddc5-46b5-a52b-e53c9218b682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Spinal Fixation System Instrument Set
• Version Model Number: LS05-0024
• Catalog Number: LS05-0024
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809986460554 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

[08809986460554]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [AccelFix Spinal Fixation System Instrument Set]

• 08809986460592: Auxiliary Lower Tray
• 08809986460585: Auxiliary Upper Tray
• 08809986460578: AccelFix-S Auxiliary Container Cover
• 08809986460561: AccelFix-S Auxiliary Container
• 08809986460554: Basic Lower Tray
• 08809986460547: Basic Middle Tray
• 08809986460530: Basic Upper Tray
• 08809986460523: AccelFix-S Basic Container Cover
• 08809986460516: AccelFix-S Basic Container