ACIS® ProTi 360™ HL 208843308

GUDID 00819917022186

ACIS PROTI 10 DG HL L 8MM H

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00819917022186
• NIH Device Record Key: ea1773bc-5a31-4cb7-b297-feaf9e9a7b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIS® ProTi 360™ HL
• Version Model Number: 208843308
• Catalog Number: 208843308
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00819917022186 [Primary]

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-05-25

On-Brand Devices [ACIS® ProTi 360™ HL]

• 00819917022605: ACIS PROTI 20 DG HL X 12MM H
• 00819917022599: ACIS PROTI 20 DG HL X 11MM H
• 00819917022582: ACIS PROTI 20 DG HL X 10MM H
• 00819917022575: ACIS PROTI 20 DG HL X 9MM H
• 00819917022568: ACIS PROTI 15 DG HL X 12MM H
• 00819917022551: ACIS PROTI 15 DG HL X 11MM H
• 00819917022544: ACIS PROTI 15 DG HL X 10MM H
• 00819917022537: ACIS PROTI 15 DG HL X 9MM H
• 00819917022520: ACIS PROTI 15 DG HL X 8MM H
• 00819917022513: ACIS PROTI 12 DG HL X 12MM H
• 00819917022506: ACIS PROTI 12DG HL X 11MM H
• 00819917022490: ACIS PROTI 12 DG HL X 10MM H
• 00819917022483: ACIS PROTI 12 DG HL X 9MM H
• 00819917022476: ACIS PROTI 12 DG HL X 8MM H
• 00819917022469: ACIS PROTI 12DG HL X 7MM H
• 00819917022452: ACIS PROTI 10 DG HL X 12MM H
• 00819917022445: ACIS PROTI 10 DG HL X 11MM H
• 00819917022438: ACIS PROTI 10 DG HL X 10MM H
• 00819917022421: ACIS PROTI 10 DG HL X 9MM H
• 00819917022414: ACIS PROTI 10 DG HL X 8MM H
• 00819917022407: ACIS PROTI 10 DG HL X 7MM H
• 00819917022391: ACIS PROTI 10 DG HL X 6MM H
• 00819917022384: ACIS PROTI 20 DG HL L 12MM H
• 00819917022377: ACIS PROTI 20 DG HL L 11MM H
• 00819917022360: ACIS PROTI 20 DG HL L 10MM H
• 00819917022353: ACIS PROTI 20 DG HL L 9MM H
• 00819917022346: ACIS PROTI 15 DG HL L 12MM H
• 00819917022339: ACIS PROTI 15 DG HL L 11MM H
• 00819917022322: ACIS PROTI 15 DG HL L 10MM H
• 00819917022315: ACIS PROTI 15 DG HL L 9MM H
• 00819917022308: ACIS PROTI 15 DG HL L 8MM H
• 00819917022292: ACIS PROTI 15 DG HL L 7MM H
• 00819917022285: ACIS PROTI 12 DG HL L 12MM H
• 00819917022278: ACIS PROTI 12DG HL L 11MM H
• 00819917022261: ACIS PROTI 12 DG HL L 10MM H
• 00819917022254: ACIS PROTI 12 DG HL L 9MM H
• 00819917022247: ACIS PROTI 12 DG HL L 8MM H
• 00819917022230: ACIS PROTI 12DG HL L 7MM H
• 00819917022223: ACIS PROTI 10 DG HL L 12MM H
• 00819917022216: ACIS PROTI 10 DG HL L 11MM H
• 00819917022209: ACIS PROTI 10 DG HL L 10MM H
• 00819917022193: ACIS PROTI 10 DG HL L 9MM H
• 00819917022186: ACIS PROTI 10 DG HL L 8MM H
• 00819917022179: ACIS PROTI 10 DG HL L 7MM H
• 00819917022162: ACIS PROTI 10 DG HL L 6MM H
• 00819917022155: ACIS PROTI 20 DG HL M 12MM H
• 00819917022148: ACIS PROTI 20 DG HL M 11MM H
• 00819917022131: ACIS PROTI 20 DG HL M 10MM H
• 00819917022124: ACIS PROTI 20 DG HL M 9MM H
• 00819917022117: ACIS PROTI 20 DG HL M 8MM H