PLIF Cage 100357-18-200913

GUDID B52310035718200913

Lordotic TPLIF Cage, Titanium 20AP X 09ML X 13HT, 18 Deg

Eisertech, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: B52310035718200913
• NIH Device Record Key: 5d684e1b-a489-401e-9bb0-591f3291b070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLIF Cage
• Version Model Number: 100357-18-200913
• Catalog Number: 100357-18-200913
• Company DUNS: 965627297
• Company Name: Eisertech, LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• 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
HIBCC	B52310035718200913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113478

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B52310035718200913]

Moist Heat or Steam Sterilization

[B52310035718200913]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-13

On-Brand Devices [PLIF Cage]

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• B5231003576270915: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 15HT, 6 Deg
• B5231003576270914: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 14HT, 6 Deg
• B5231003576270913: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 13HT, 6 Deg
• B5231003576270912: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 12HT, 6 Deg
• B5231003576270911: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 11HT, 6 Deg
• B5231003576270910: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 10HT, 6 Deg
• B5231003576250916: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 16HT, 6 Deg
• B5231003576250915: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 15HT, 6 Deg
• B5231003576250914: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 14HT, 6 Deg
• B5231003576250913: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 13HT, 6 Deg
• B5231003576250912: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 12HT, 6 Deg
• B5231003576250911: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 11HT, 6 Deg
• B5231003576250910: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 10HT, 6 Deg
• B5231003576250909: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 09HT, 6 Deg
• B5231003576250908: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 08HT, 6 Deg
• B5231003576200916: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 16HT, 6 Deg
• B5231003576200915: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 15HT, 6 Deg
• B5231003576200914: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 14HT, 6 Deg
• B5231003576200913: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 13HT, 6 Deg
• B5231003576200912: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 12HT, 6 Deg
• B5231003576200911: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 11HT, 6 Deg
• B5231003576200910: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 10HT, 6 Deg
• B5231003576200909: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 09HT, 6 Deg
• B5231003576200908: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 08HT, 6 Deg
• B52310035718270916: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 16HT, 18 Deg
• B52310035718270915: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 15HT, 18 Deg
• B52310035718270914: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 14HT, 18 Deg
• B52310035718270913: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 13HT, 18 Deg
• B52310035718250916: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 16HT, 18 Deg
• B52310035718250915: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 15HT, 18 Deg
• B52310035718250914: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 14HT, 18 Deg
• B52310035718250913: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 13HT, 18 Deg
• B52310035718230912: Lordotic TPLIF Cage, Titanium 23AP X 09ML X 126HT, 18 Deg
• B52310035718200916: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 16HT, 18 Deg
• B52310035718200915: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 15HT, 18 Deg
• B52310035718200914: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 14HT, 18 Deg
• B52310035718200913: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 13HT, 18 Deg
• B52310035718200912: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 12HT, 18 Deg
• B52310035718200911: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 11HT, 18 Deg
• B52310035718200910: Lordotic TPLIF Cage, Titanium 20AP X 09ML X 10HT, 18 Deg
• B52310035712270916: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 16HT, 12 Deg
• B52310035712270915: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 15HT, 12 Deg
• B52310035712270914: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 14HT, 12 Deg
• B52310035712270913: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 13HT, 12 Deg
• B52310035712270912: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 12HT, 12 Deg
• B52310035712270911: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 11HT, 12 Deg
• B52310035712250916: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 16HT, 12 Deg
• B52310035712250915: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 15HT, 12 Deg
• B52310035712250914: Lordotic TPLIF Cage, Titanium 25AP X 09ML X 14HT, 12 Deg