ShurFit MALIF System 50-0016

GUDID 00840019925501

ShurFit™ MALIF Implant Case (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019925501
• NIH Device Record Key: 9b58ee0e-fa8d-42c7-9e7f-d02c665c97de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit MALIF System
• Version Model Number: 50-0016
• Catalog Number: 50-0016
• 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	00840019925501 [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

[00840019925501]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [ShurFit MALIF System]

• 00840019925501: ShurFit™ MALIF Implant Case (Empty)
• 00840019925495: ShurFit™ MALIF Instrument Case # 2 (Empty)
• 00840019925488: ShurFit™ MALIF Instrument Case # 1 (Empty)
• 00840019925471: MALIF Sizer 22x50x14mm
• 00840019925464: MALIF Sizer 22x50x12mm
• 00840019925457: MALIF Sizer 22x50x10mm
• 00840019925440: MALIF Sizer 22x50x08mm
• 00840019925433: MALIF Sizer 18x50x14mm
• 00840019925426: MALIF Sizer 18x50x12mm
• 00840019925402: MALIF Sizer 18x50x08mm
• 00840019925396: Angled Cobb 22mm
• 00840019925365: Straight Cobb 18mm
• 00840019925358: Large Chisel 12mm Width
• 00840019925341: Small Chisel 6mm Width
• 00840019925334: Paddle Shaver 50mm Length x 14mm Height
• 00840019925303: Paddle Shaver 50mm Length x 08mm Height
• 00840019925297: Paddle Shaver 50mm Length x 06mm Height
• 00840019925273: Cup Curette 6mm x 90˚ Up Pulling
• 00840019925266: Cup Curette 6mm x 45˚Up Pulling
• 00840019925235: Cup Curette 4mm x 45˚ Up Pulling
• 00840019925211: Disc Spreader
• 00840019925181: Implant Slides
• 00840019925174: Implant Extractor
• 00840019925150: Box Curette 8mm
• 00840019925136: Ring Curette 8mm Large
• 00840019925129: Ring Curette 6mm Small
• 00840019925112: Rasp
• 00840019916387: Rongeurs Pituitary Straight Kerrison 6mm x 330mm
• 00840019916370: Rongeurs Pituitary Straight Kerrison 4mm x 330mm
• 00840019916363: Punch Kerrison Lamina 40˚ Up Bite 6mm x 330mm
• 00840019916356: Punch Kerrison Lamina 40˚ Up Bite 4mm x 330mm
• 00840019925419: MALIF Sizer 18x50x10mm
• 00840019925327: Paddle Shaver 50mm Length x 12mm Height
• 00840019925310: Paddle Shaver 50mm Length x 10mm Height
• 00840019925280: T Handle Quick Connect
• 00840019925259: Cup Curette 6mm Straight Up Cup
• 00840019925242: Cup Curette 4mm 90˚ Up Pulling
• 00840019925228: Cup Curette 4mm Straight Up Cup
• 00840019925204: LLIF Slap Hammer
• 00840019925198: LLIF Tamp
• 00840019925167: LLIF Inserter Tool
• 00840019925143: Box Curette 6mm