AccelFix Lumbar Plate System 7102-5530S

GUDID 08800061643602

AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 30mm

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800061643602
• NIH Device Record Key: 6b97d81e-82bf-4a6b-8fa3-8c15abd97578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Lumbar Plate System
• Version Model Number: 7102-5530S
• Catalog Number: 7102-5530S
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	08800061643602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192481

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

On-Brand Devices [AccelFix Lumbar Plate System]

• 08800061394436: AccelFix Lumbar Plate (2 Hole type), 30mm, Blue
• 08800061394429: AccelFix Lumbar Plate (2 Hole type), 28mm, Blue
• 08800061394412: AccelFix Lumbar Plate (2 Hole type), 27mm, Blue
• 08800061394405: AccelFix Lumbar Plate (2 Hole type), 26mm, Blue
• 08800061394399: AccelFix Lumbar Plate (2 Hole type), 30mm, Blue
• 08800061394382: AccelFix Lumbar Plate (2 Hole type), 28mm, Blue
• 08800061394375: AccelFix Lumbar Plate (2 Hole type), 27mm, Blue
• 08800061394368: AccelFix Lumbar Plate (2 Hole type), 26mm, Blue
• 08800061399974: AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 45mm
• 08800061399967: AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 40mm
• 08800061399950: AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 35mm
• 08800061399943: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 45mm
• 08800061399936: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 40mm
• 08800061399929: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 35mm
• 08800061644005: AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 30mm
• 08800061643992: AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi6.0, 25mm
• 08800061643985: AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 20mm
• 08800061643923: AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 30mm
• 08800061643916: AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 25mm
• 08800061643909: AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 20mm
• 08800061643688: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 30mm
• 08800061643671: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 25mm
• 08800061643664: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 20mm
• 08800061643602: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 30mm
• 08800061643596: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 25mm
• 08800061643589: AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 20mm