INTERBODY FUSION DEVICES 23-PC2260-12

GUDID 00815362023235

SHURFIT LLIF PEEK 22x60x12mm (qty 21)

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00815362023235
• NIH Device Record Key: 025e1fab-3e67-4255-b13e-4501d4761472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERBODY FUSION DEVICES
• Version Model Number: 11105PS
• Catalog Number: 23-PC2260-12
• 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: 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	00815362023235 [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

[00815362023235]

Moist Heat or Steam Sterilization

[00815362023235]

Moist Heat or Steam Sterilization

[00815362023235]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-11-15

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