ShurFit Interbody Deviceem 26-221000-12

GUDID 00840019910224

Wide PLIF Cage Peek 0 degree 22 x 10 X 12

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019910224
• NIH Device Record Key: 19fe4176-f7bf-4e07-934f-31a64157adde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit Interbody Deviceem
• Version Model Number: 26-221000-12
• Catalog Number: 26-221000-12
• 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	00840019910224 [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

[00840019910224]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-23

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