Dakota ALIF System 69-SC-1608

GUDID 00840019968614

Standard Cage Implant Caddy - 36 x 28mm x 8°

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019968614
• NIH Device Record Key: 937a9bd0-6da2-433b-a4ce-ef813f030787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dakota ALIF System
• Version Model Number: 69-SC-1608
• Catalog Number: 69-SC-1608
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00840019968614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213118

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

[00840019968614]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-19
• Device Publish Date: 2025-03-11

On-Brand Devices [Dakota ALIF System]

• 00840019968355: Large Cage Insertion Tips Kit (39 & 42mm)
• 00840019968348: Large Cage Insertion Tips Caddy (39 & 42mm)
• 00840019968300: Disc Distractor Kit
• 00840019968843: Large Cage Implant Kit - 42 x 30mm x 25° & 30mm°
• 00840019968836: Large Cage Implant Caddy - 42 x 30mm x 25° & 30mm°
• 00840019968829: Large Cage Implant Kit - 42 x 30mm x 20°
• 00840019968812: Large Cage Implant Caddy - 42 x 30mm x 20°
• 00840019968805: Large Cage Implant Kit - 42 x 30mm x 15°
• 00840019968799: Large Cage Implant Caddy - 42 x 30mm x 15°
• 00840019968782: Large Cage Implant Kit - 42 x 30mm x 8°
• 00840019968775: Large Cage Implant Caddy - 42 x 30mm x 8°
• 00840019968768: Large Cage Implant Kit - 39 x 29mm x 25° & 30°
• 00840019968751: Large Cage Implant Caddy - 39 x 29mm x 25° & 30°
• 00840019968744: Large Cage Implant Kit - 39 x 29mm x 20°
• 00840019968737: Large Cage Implant Caddy - 39 x 29mm x 20°
• 00840019968720: Large Cage Implant Kit - 39 x 29mm x 15°
• 00840019968713: Large Cage Implant Caddy - 39 x 29mm x 15°
• 00840019968706: Large Cage Implant Kit - 39 x 29mm x 8°
• 00840019968690: Large Cage Implant Caddy - 39 x 29mm x 8°
• 00840019968683: Standard Cage Implant Kit - 36 x 28mm x 25° & 30°
• 00840019968676: Standard Cage Implant Caddy - 36 x 28mm x 25° & 30°
• 00840019968669: Standard Cage Implant Kit - 36 x 28mm x 20°
• 00840019968652: Standard Cage Implant Caddy - 36 x 28mm x 20°
• 00840019968645: Standard Cage Implant Kit - 36 x 28mm x 15°
• 00840019968638: Standard Cage Implant Caddy - 36 x 28mm x 15°
• 00840019968621: Standard Cage Implant Kit - 36 x 28mm x 8°
• 00840019968614: Standard Cage Implant Caddy - 36 x 28mm x 8°
• 00840019968607: Standard Cage Implant Kit - 33 x 27mm x 25° & 30°
• 00840019968591: Standard Cage Implant Caddy - 33 x 27mm x 25° & 30°
• 00840019968584: Standard Cage Implant Kit - 33 x 27mm x 20°
• 00840019968577: Standard Cage Implant Caddy - 33 x 27mm x 20°
• 00840019968560: Standard Cage Implant Kit - 33 x 27mm x 15°
• 00840019968553: Standard Cage Implant Caddy - 33 x 27mm x 15°
• 00840019968546: Standard Cage Implant Kit - 33 x 27mm x 8°
• 00840019968539: Standard Cage Implant Caddy - 33 x 27mm x 8°
• 00840019968522: Standard Cage Implant Kit - 30 x 26mm x 25° & 30°
• 00840019968515: Standard Cage Implant Caddy - 30 x 26mm x 25° & 30°
• 00840019968508: Standard Cage Implant Kit - 30 x 26mm x 20°
• 00840019968492: Standard Cage Implant Caddy - 30 x 26mm x 20°
• 00840019968485: Standard Cage Implant Kit - 30 x 26mm x 15°
• 00840019968478: Standard Cage Implant Caddy - 30 x 26mm x 15°
• 00840019968461: Standard Cage Implant Kit - 30 x 26mm x 8°
• 00840019968454: Standard Cage Implant Caddy - 30 x 26mm x 8°
• 00840019968447: Disc Distractor Tip Kit
• 00840019968430: Disc Distractor Tip Caddy
• 00840019968423: Standard Cage Insertion Tip Kit (30, 33, & 36mm)
• 00840019968416: Standard Cage Insertion Tip Caddy (30, 33, & 36mm)
• 00840019969048: 30 X 26 X 15mm X 20° Trial Rasp
• 00840019969031: 30 X 26 X 13mm X 20° Trial Rasp
• 00840019969024: 30 X 26 X 19mm X 15° Trial Rasp