ShurFit MALIF Interbody System 23-9101

GUDID 00840019936880

ShurFit™ MALIF Instrument Case # 1

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019936880
• NIH Device Record Key: d64ce4b4-45a7-466e-a553-99d6d6726894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit MALIF Interbody System
• Version Model Number: 23-9101
• Catalog Number: 23-9101
• 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: 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	00840019936880 [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

[00840019936880]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [ShurFit MALIF Interbody System]

• 00840019936903: ShurFit™ MALIF Implant Case
• 00840019936897: ShurFit™ MALIF Instrument Case # 2
• 00840019936880: ShurFit™ MALIF Instrument Case # 1
• 00840019925389: Angled Cobb 18mm
• 00840019925372: Straight Cobb 22mm