Dakota ALIF Plate System 69-AM-2013-2C

GUDID 00840019963152

33X 27 X 13mm X 20° PEEK-2C

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019963152
• NIH Device Record Key: ff049eb6-1ea1-453d-be13-a9b5505d43d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dakota ALIF Plate System
• Version Model Number: 69-AM-2013-2C
• Catalog Number: 69-AM-2013-2C
• 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	00840019963152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212937

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

[00840019963152]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-01
• Device Publish Date: 2022-01-24

On-Brand Devices [Dakota ALIF Plate System]

• 00840019961707: 30X 26 X 19mm X 15° PEEK
• 00840019961691: 30X 26 X 17mm X 15° PEEK
• 00840019961684: 30X 26 X 15mm X 15° PEEK
• 00840019961677: 30X 26 X 13mm X 15° PEEK
• 00840019961660: 30X 26 X 11mm X 15° PEEK
• 00840019961653: 30X 26 X 19mm X 8° PEEK
• 00840019961646: 30X 26 X 17mm X 8° PEEK
• 00840019961639: 30X 26 X 15mm X 8° PEEK
• 00840019961622: 30X 26 X 13mm X 8° PEEK
• 00840019961615: 30X 26 X 11mm X 8° PEEK
• 00840019961608: 30 X 26 X 19mm X 0° PEEK
• 00840019961592: 30 X 26 X 17mm X 0° PEEK
• 00840019961585: 30 X 26 X 15mm X 0° PEEK
• 00840019961578: 30 X 26 X 13mm X 0° PEEK
• 00840019961561: 30 X 26 X 11mm X 0° PEEK
• 00840019962001: 33X 27 X 17mm X 25° PEEK
• 00840019961998: 33X 27 X 15mm X 25° PEEK
• 00840019961981: 33X 27 X 19mm X 20° PEEK
• 00840019961974: 33X 27 X 17mm X 20° PEEK
• 00840019961967: 33X 27 X 15mm X 20° PEEK
• 00840019961950: 33X 27 X 13mm X 20° PEEK
• 00840019961943: 33X 27 X 19mm X 15° PEEK
• 00840019961936: 33X 27 X 17mm X 15° PEEK
• 00840019961929: 33X 27 X 15mm X 15° PEEK
• 00840019961912: 33X 27 X 13mm X 15° PEEK
• 00840019961905: 33X 27 X 11mm X 15° PEEK
• 00840019961899: 33X 27 X 19mm X 8° PEEK
• 00840019961882: 33X 27 X 17mm X 8° PEEK
• 00840019961875: 33X 27 X 15mm X 8° PEEK
• 00840019961868: 33X 27 X 13mm X 8° PEEK
• 00840019961851: 33X 27 X 11mm X 8° PEEK
• 00840019961844: 33 X 27 X 19mm X 0° PEEK
• 00840019961837: 33 X 27 X 17mm X 0° PEEK
• 00840019961820: 33 X 27 X 15mm X 0° PEEK
• 00840019961813: 33 X 27 X 13mm X 0° PEEK
• 00840019961806: 33 X 27 X 11mm X 0° PEEK
• 00840019961790: 30X 26 X 19mm X 30° PEEK
• 00840019961783: 30X 26 X 17mm X 30° PEEK
• 00840019961776: 30X 26 X 19mm X 25° PEEK
• 00840019961769: 30X 26 X 17mm X 25° PEEK
• 00840019961752: 30X 26 X 15mm X 25° PEEK
• 00840019961745: 30X 26 X 19mm X 20° PEEK
• 00840019961738: 30X 26 X 17mm X 20° PEEK
• 00840019961721: 30X 26 X 15mm X 20° PEEK
• 00840019961714: 30X 26 X 13mm X 20° PEEK
• 00840019962131: 36X 28 X 19mm X 8° PEEK
• 00840019962124: 36X 28 X 17mm X 8° PEEK
• 00840019962117: 36X 28 X 15mm X 8° PEEK
• 00840019962100: 36X 28 X 13mm X 8° PEEK
• 00840019962094: 36X 28 X 11mm X 8° PEEK