AccelFix Lumbar Plate System 7302-6035S

GUDID 08800061399950

AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 35mm

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800061399950
• NIH Device Record Key: 19c41ecb-47c1-4f7c-be02-91397e1ca522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Lumbar Plate System
• Version Model Number: 7302-6035S
• Catalog Number: 7302-6035S
• 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	08800061399950 [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: 2023-12-07
• Device Publish Date: 2023-11-29

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