Anterior Lumbar Plate System 50-0002

GUDID 00840019925587

AccuFit™ ALIF Case (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019925587
• NIH Device Record Key: 47627933-344d-4cf9-875e-1e4cf3a939d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Lumbar Plate System
• Version Model Number: 50-0002
• Catalog Number: 50-0002
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019925587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091044

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019925587]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-28
• Device Publish Date: 2019-03-27

On-Brand Devices [Anterior Lumbar Plate System ]

• 00840019925587: AccuFit™ ALIF Case (Empty)
• 00840019925570: Drill Guide
• 00840019925563: ALP Awl
• 00840019925556: 3.5 Hex Screwdriver
• 00840019925532: ALIF Plate Locking Tool
• 00840019925525: ALIF Plate Holder
• 00840019925518: ALIF Plate Lock/Unlock Tool
• 00840019925549: ALIF Drill 25mm