Dakota ACDF System 71-AL-4211

GUDID 00840019940719

14 x 12 x 11mm 7° Interbody

PRECISION SPINE, INC.

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• Primary Device ID: 00840019940719
• NIH Device Record Key: adad3a31-8d7f-4bee-a806-9831f4b80444
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dakota ACDF System
• Version Model Number: 71-AL-4211
• Catalog Number: 71-AL-4211
• 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: true
• 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	00840019940719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203129

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

[00840019940719]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [Dakota ACDF System]

• 00840019941273: ø4.0 x 18mm Self-Tapping Screw
• 00840019941266: ø4.0 x 17mm Self-Tapping Screw
• 00840019941259: ø4.0 x 15mm Self-TappingScrew
• 00840019941242: ø4.0 x 14mm Self-Tapping Screw
• 00840019941235: ø4.0 x 12mm Self-Tapping Screw
• 00840019941228: ø3.5 x 18mm Self-Tapping Screw
• 00840019941211: ø3.5 x 17mm Self-Tapping Screw
• 00840019941204: ø3.5 x 15mm Self-Tapping Screw
• 00840019941198: ø3.5 x 14mm Self-Tapping Screw
• 00840019941181: ø3.5 x 12mm Self-Tapping Screw
• 00840019941174: ø4.0 x 18mm Self-Drilling Screw
• 00840019941167: ø4.0 x 17mm Self-Drilling Screw
• 00840019941150: ø4.0 x 15mm Self-Drilling Screw
• 00840019941143: ø4.0 x 14mm Self-Drilling Screw
• 00840019941136: ø4.0 x 12mm Self-Drilling Screw
• 00840019941129: ø3.5 x 18mm Self-Drilling Screw
• 00840019941112: ø3.5 x 17mm Self-Drilling Screw
• 00840019941105: ø3.5 x 15mm Self-Drilling Screw
• 00840019941099: ø3.5 x 14mm Self-Drilling Screw
• 00840019941082: ø3.5 x 12mm Self-Drilling Screw
• 00840019941914: Screw Tap - 14mm
• 00840019941907: Screw Tap - 12mm
• 00840019941846: Angled Awl
• 00840019941785: Drill Guide
• 00840019941778: Straight Awl
• 00840019941754: Rasp, 7° Lordosis, 18x15 - 11/12mm
• 00840019941747: Rasp, 7° Lordosis, 18x15 - 9/10mm
• 00840019941730: Rasp, 7° Lordosis, 18x15 - 7/8mm
• 00840019941723: Rasp, 7° Lordosis, 18x15 - 5/6mm
• 00840019941716: Rasp, 7° Lordosis, 16x14 - 11/12mm
• 00840019941709: Rasp, 7° Lordosis, 16x14 - 9/10mm
• 00840019941693: Rasp, 7° Lordosis, 16x14 - 7/8mm
• 00840019941686: Rasp, 7° Lordosis, 16x14 - 6mm
• 00840019941679: Rasp, 7° Lordosis, 14x12 - 11/12mm
• 00840019941662: Rasp, 7° Lordosis, 14x12 - 9/10mm
• 00840019941655: Rasp, 7° Lordosis, 14x12 - 7/8mm
• 00840019941648: Rasp, 7° Lordosis, 14x12 - 5/6mm
• 00840019941631: Rasp, 0° Lordosis, 18x15 - 11/12mm
• 00840019941624: Rasp, 0° Lordosis, 18x15 - 9/10mm
• 00840019941617: Rasp, 0° Lordosis, 18x15 - 7/8mm
• 00840019941600: Rasp, 0° Lordosis, 18x15 - 5/6mm
• 00840019941594: Rasp, 0° Lordosis, 16x14 - 11/12mm
• 00840019941587: Rasp, 0° Lordosis, 16x14 - 9/10mm
• 00840019941570: Rasp, 0° Lordosis, 16x14 - 7/8mm
• 00840019941563: Rasp, 0° Lordosis, 16x14 - 6mm
• 00840019941556: Rasp, 0° Lordosis, 14x12 - 11/12mm
• 00840019941549: Rasp, 0° Lordosis, 14x12 - 9/10mm
• 00840019941532: Rasp, 0° Lordosis, 14x12 - 7/8mm
• 00840019941525: Rasp, 0° Lordosis, 14x12 - 5/6mm
• 00840019941518: Trial, 7° Lordosis, 18x15 - 11/12mm