Anterior Cervical Interbody Fusion Device 50-0003

GUDID 00840019921909

Shurfit ACIF Case

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019921909
• NIH Device Record Key: 209f4095-7f22-4eb5-aa62-0d120cf14ce7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical Interbody Fusion Device
• Version Model Number: 50-0003
• Catalog Number: 50-0003
• 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	00840019921909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083118

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00840019921909]

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 [ Anterior Cervical Interbody Fusion Device]

• 00840019921909: Shurfit ACIF Case
• 00840019921879: ACIF Rasp, Wide, 2mm Stop (11mm Height)
• 00840019921862: ACIF Rasp, Wide, 2mm Stop (10mm Height)
• 00840019921855: ACIF Rasp, Wide, 2mm Stop (9mm Height)
• 00840019921831: ACIF Rasp, Wide, 2mm Stop (7mm Height)
• 00840019921824: ACIF Rasp, Wide, 2mm Stop (6mm Height)
• 00840019921794: ACIF Rasp, Wide, w/o Stop (11mm Height)
• 00840019921770: ACIF Rasp, Wide, w/o Stop (9mm Height)
• 00840019921763: ACIF Rasp, Wide, w/o Stop (8mm Height)
• 00840019921756: ACIF Rasp, Wide, w/o Stop (7mm Height)
• 00840019921749: ACIF Rasp, Wide, w/o Stop (6mm Height)
• 00840019921725: ACIF Rasp, Narrow, 2mm Stop (12mm Height)
• 00840019921718: ACIF Rasp, Narrow, 2mm Stop (11mm Height)
• 00840019921701: ACIF Rasp, Narrow, 2mm Stop (10mm Height)
• 00840019921695: ACIF Rasp, Narrow, 2mm Stop (9mm Height)
• 00840019921688: ACIF Rasp, Narrow, 2mm Stop (8mm Height)
• 00840019921671: ACIF Rasp, Narrow, 2mm Stop (7mm Height)
• 00840019921664: ACIF Rasp, Narrow, 2mm Stop (6mm Height)
• 00840019921657: ACIF Rasp, Narrow, 2mm Stop (5mm Height)
• 00840019921640: ACIF Rasp, Narrow, w/o Stop (12mm Height)
• 00840019921633: ACIF Rasp, Narrow, w/o Stop (11mm Height)
• 00840019921626: ACIF Rasp, Narrow, w/o Stop (10mm Height)
• 00840019921619: ACIF Rasp, Narrow, w/o Stop (9mm Height)
• 00840019921602: ACIF Rasp, Narrow, w/o Stop (8mm Height)
• 00840019921596: ACIF Rasp, Narrow, w/o Stop (7mm Height)
• 00840019921589: ACIF Rasp, Narrow, w/o Stop (6mm Height)
• 00840019921572: ACIF Rasp, Narrow, w/o Stop (5mm Height)
• 00840019921565: Cervical Sizer 12mm
• 00840019921558: Cervical Sizer 11mm
• 00840019921541: Cervical Sizer 10mm
• 00840019921534: Cervical Sizer 9mm
• 00840019921527: Cervical Sizer 8mm
• 00840019921510: Cervical Sizer 7mm
• 00840019921503: Cervical Sizer 6mm
• 00840019921497: Cervical Sizer 5mm
• 00840019916349: ACIF Tamp
• 00815362022467: ACIF Inserter
• 00840019921893: ACIF System Tray
• 00840019921886: ACIF Rasp, Wide, 2mm Stop (12mm Height)
• 00840019921848: ACIF Rasp, Wide, 2mm Stop (8mm Height)
• 00840019921817: ACIF Rasp, Wide, 2mm Stop (5mm Height)
• 00840019921800: ACIF Rasp, Wide, w/o Stop (12mm Height)
• 00840019921787: ACIF Rasp, Wide, w/o Stop (10mm Height)
• 00840019921732: ACIF Rasp, Wide, w/o Stop (5mm Height)