Anterior Cervical Interbody Fusion Device 45-10-10P

GUDID 00840019908238

ACIF-Wide 10 degree 10mm

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019908238
• NIH Device Record Key: ce3aa145-1c6e-435e-a91f-d29ac472b0b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical Interbody Fusion Device
• Version Model Number: 45-10-10P
• Catalog Number: 45-10-10P
• 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	00840019908238 [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

[00840019908238]

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: 2019-04-12

On-Brand Devices [Anterior Cervical Interbody Fusion Device]

• 00840019922142: ACIF Wide System (Empty)
• 00840019922135: Implant caddy
• 00840019922128: Outer case
• 00840019922111: ACIF Wide System Assembly
• 00840019922104: ACIF-Wide 12mm Sizer
• 00840019922098: ACIF-Wide 11mm Sizer
• 00840019922074: ACIF-Wide 9mm Sizer
• 00840019922067: ACIF-Wide 8mm Sizer
• 00840019922050: ACIF-Wide 7mm Sizer
• 00840019922029: Sterilization Case Assembly
• 00840019922012: Implant Caddy
• 00840019922005: Sterilization Case
• 00840019921992: Inserter Assembly
• 00840019921985: 5° & 10° X 12mm Trial Assembly
• 00840019921978: 5° & 10° X 11mm Trial Assembly
• 00840019921961: 5° & 10° X 10mm Trial Assembly
• 00840019921947: 5° & 10° X 8mm Trial Assembly
• 00840019921923: 5° & 10° X 6mm Trial Assembly
• 00840019922081: ACIF-Wide 10mm Sizer
• 00840019922043: ACIF-Wide 6mm Sizer
• 00840019922036: ACIF-Wide 5mm Sizer
• 00840019921954: 5° & 10° X 9mm Trial Assembly
• 00840019921930: 5° & 10° X 7mm Trial Assembly
• 00840019921916: 5° & 10° X 5mm Trial Assembly
• 00840019907859: ACIF Cage Peek 5 degree x 12mm
• 00840019907842: ACIF Cage Peek 5 degree x 11mm
• 00840019907835: ACIF Cage Peek 5 degree x 10mm
• 00840019907828: ACIF Cage Peek 5 degree x 9mm
• 00840019907811: ACIF Cage Peek 5 degree x 8mm
• 00840019907804: ACIF Cage Peek 5 degree x 7mm
• 00840019907798: ACIF Cage Peek 5 degree x 6mm
• 00840019907781: ACIF Cage Peek 5 degree x 5mm
• 00840019908252: ACIF-Wide 10 degree 12mm
• 00840019908245: ACIF-Wide 10 degree 11mm
• 00840019908238: ACIF-Wide 10 degree 10mm
• 00840019908221: ACIF-Wide 10 degree 9mm
• 00840019908214: ACIF-Wide 10 degree 8mm
• 00840019908207: ACIF-Wide 10 degree 7mm
• 00840019908191: ACIF-Wide 10 degree 6mm
• 00840019908184: ACIF-Wide 10 degree 5mm
• 00840019908177: ACIF-Wide 5 degree 12mm
• 00840019908160: ACIF-Wide 5 degree 11mm
• 00840019908153: ACIF-Wide 5 degree 10mm
• 00840019908146: ACIF-Wide 5 degree 9mm
• 00840019908139: ACIF-Wide 5 degree 8mm
• 00840019908122: ACIF-Wide 5 degree 7mm
• 00840019908115: ACIF-Wide 5 degree 6mm
• 00840019908108: ACIF-Wide 5 degree 5mm
• 00840019907934: ACIF Cage Peek 10 degree x 12 mm
• 00840019907927: ACIF Cage Peek 10 degree x 11 mm