AccuFit ALIF Plate System 01-V5530

GUDID 00840019912655

5.5mm x 30mm Self Drilling Variable Screw

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019912655
• NIH Device Record Key: d96c790e-1567-4671-8967-1002e16db062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuFit ALIF Plate System
• Version Model Number: 01-V5530
• Catalog Number: 01-V5530
• 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: true
• 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	00840019912655 [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

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

[00840019912655]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [AccuFit ALIF Plate System]

• 00840019912662: 5.5mm x 35mm Self Drilling Variable Screw
• 00840019912655: 5.5mm x 30mm Self Drilling Variable Screw
• 00840019912648: 5.5mm x 25mm Self Drilling Variable Screw
• 00840019912631: 5.0mm x 35mm Self Drilling Variable Screw
• 00840019912624: 5.0mm x 30mm Self Drilling Variable Screw
• 00840019912617: 5.0mm x 25mm Self Drilling Variable Screw
• 00840019912600: 5.5mm X 35mm Self Drilling Fixed Screw
• 00840019912594: 5.5mm X 30mm Self Drilling Fixed Screw
• 00840019912587: 5.5mm X 25mm Self Drilling Fixed Screw
• 00840019912570: 5.0mm X 35mm Self Drilling Fixed Screw
• 00840019912563: 5.0mm X 30mm Self Drilling Fixed Screw
• 00840019912556: 5.0mm X 25mm Self Drilling Fixed Screw
• 00840019912549: ALIF Fixation Pin
• 00840019912532: ALIF Plate 27mm for L5-S1
• 00840019912525: ALIF Plate 25mm for L5-S1
• 00840019912518: ALIF Plate 23mm for L5-S1
• 00840019912501: ALIF Plate 21mm for L5-S1
• 00840019912495: ALIF Plate 27mm for L4-L5
• 00840019912488: ALIF Plate 25mm for L4-L5
• 00840019912471: ALIF Plate 23mm for L4-L5
• 00840019912464: ALIF Plate 21mm for L4-L5
• 00840019936910: ALIF Plate Tray