AccelFix Lumbar Expandable Cage System 5520-1012

GUDID 08800061638424

AccelFix-XTP, 12°, 55X20X10mm

L&K BIOMED CO. ,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800061638424
• NIH Device Record Key: 18181c02-9297-4248-8303-2fe97aefadad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Lumbar Expandable Cage System
• Version Model Number: 5520-1012
• Catalog Number: 5520-1012
• 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	08800061638424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190708

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

[08800061638424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-10-09

On-Brand Devices [AccelFix Lumbar Expandable Cage System]

• 08800061635928: AccelFix-XT, 0°, 22X11X8mm
• 08800061635867: AccelFix-XT, 8°, 22X11X8mm
• 08800061635850: AccelFix-XT, 8°, 22X11X10mm
• 08800061635805: AccelFix-XT, 15°, 22X11X8mm
• 08800061631029: AccelFix-XT, 8°, 22X11X12mm
• 08800061635911: AccelFix-XT, 0°, 22X11X10mm
• 08800061631050: AccelFix-XT, 12°, 22X11X12mm
• 08800061631036: AccelFix-XT, 12°, 22X11X8mm
• 08800061630992: AccelFix-XT, 4°, 22X11X12mm
• 08800061630985: AccelFix-XT, 4°, 22X11X10mm
• 08800061630978: AccelFix-XT, 4°, 22X11X8mm
• 08800061630961: AccelFix-XT, 0°, 22X11X12mm
• 08800061637656: AccelFix-XTP, 0°, 65X18X6mm
• 08800061637649: AccelFix-XTP, 12°, 60X18X10mm
• 08800061637632: AccelFix-XTP, 12°, 60X18X8mm
• 08800061637625: AccelFix-XTP, 12°, 60X18X6mm
• 08800061637618: AccelFix-XTP, 9°, 60X18X10mm
• 08800061637601: AccelFix-XTP, 9°, 60X18X8mm
• 08800061637595: AccelFix-XTP, 9°, 60X18X6mm
• 08800061637588: AccelFix-XTP, 6°, 60X18X10mm
• 08800061637571: AccelFix-XTP, 6°, 60X18X8mm
• 08800061637564: AccelFix-XTP, 6°, 60X18X6mm
• 08800061637557: AccelFix-XTP, 0°, 60X18X10mm
• 08800061637540: AccelFix-XTP, 0°, 60X18X8mm
• 08800061637533: AccelFix-XTP, 0°, 60X18X7mm
• 08800061637526: AccelFix-XTP, 0°, 60X18X6mm
• 08800061637519: AccelFix-XTP, 12°, 55X18X10mm
• 08800061637502: AccelFix-XTP, 12°, 55X18X8mm
• 08800061637496: AccelFix-XTP, 12°, 55X18X6mm
• 08800061637489: AccelFix-XTP, 9°, 55X18X10mm
• 08800061637472: AccelFix-XTP, 9°, 55X18X8mm
• 08800061637465: AccelFix-XTP, 9°, 55X18X6mm
• 08800061637458: AccelFix-XTP, 6°, 55X18X10mm
• 08800061637441: AccelFix-XTP, 6°, 55X18X8mm
• 08800061637434: AccelFix-XTP, 6°, 55X18X6mm
• 08800061637427: AccelFix-XTP, 0°, 55X18X10mm
• 08800061637410: AccelFix-XTP, 0°, 55X18X8mm
• 08800061637403: AccelFix-XTP, 0°, 55X18X7mm
• 08800061637397: AccelFix-XTP, 0°, 55X18X6mm
• 08800061637380: AccelFix-XTP, 12°, 50X18X10mm
• 08800061637373: AccelFix-XTP, 12°, 50X18X8mm
• 08800061637366: AccelFix-XTP, 12°, 50X18X6mm
• 08800061637359: AccelFix-XTP, 9°, 50X18X10mm
• 08800061637342: AccelFix-XTP, 9°, 50X18X8mm
• 08800061637335: AccelFix-XTP, 9°, 50X18X6mm
• 08800061637328: AccelFix-XTP, 6°, 50X18X10mm
• 08800061637311: AccelFix-XTP, 6°, 50X18X8mm
• 08800061637304: AccelFix-XTP, 6°, 50X18X6mm
• 08800061637298: AccelFix-XTP, 0°, 50X18X10mm
• 08800061637281: AccelFix-XTP, 0°, 50X18X8mm