ShurFit Interbody System ALIF36-11

GUDID 00840019942867

36mm x 25mm x 11mm, 9° ALIF Interbody

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019942867
• NIH Device Record Key: 8b8bbcf5-1c4d-4ed9-88cc-87d932653011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit Interbody System
• Version Model Number: ALIF36-11
• Catalog Number: ALIF36-11
• 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	00840019942867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

[00840019942867]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-17
• Device Publish Date: 2021-06-09

On-Brand Devices [ShurFit Interbody System]

• 00840019942904: 36mm x 25mm x 19mm, 9° ALIF Interbody
• 00840019942898: 36mm x 25mm x 17mm, 9° ALIF Interbody
• 00840019942881: 36mm x 25mm x 15mm, 9° ALIF Interbody
• 00840019942874: 36mm x 25mm x 13mm, 9° ALIF Interbody
• 00840019942867: 36mm x 25mm x 11mm, 9° ALIF Interbody
• 00840019942850: 36mm x 25mm x 9mm, 7° ALIF Interbody
• 00840019942843: 30mm x 22mm x 19mm, 10° ALIF Interbody
• 00840019942836: 30mm x 22mm x 17mm, 10° ALIF Interbody
• 00840019942829: 30mm x 22mm x 15mm, 10° ALIF Interbody
• 00840019942812: 30mm x 22mm x 13mm, 10° ALIF Interbody
• 00840019942805: 30mm x 22mm x 11mm, 10° ALIF Interbody
• 00840019942799: 30mm x 22mm x 9mm, 8° ALIF Interbody