PLIF Cage 100035-301015

GUDID B523100035301015

PLIF CAGE, NON-LORDOTIC, 30AP X 10ML X 15HT

Eisertech, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B523100035301015
• NIH Device Record Key: d209f7d3-9ba3-46e9-a2a8-f6415b1f9814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLIF Cage
• Version Model Number: 100035-301015
• Catalog Number: 100035-301015
• 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	B523100035301015 [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

[B523100035301015]

Moist Heat or Steam Sterilization

[B523100035301015]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-04-11

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• 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
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• B52310035718270915: Lordotic TPLIF Cage, Titanium 27AP X 09ML X 15HT, 18 Deg
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• 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
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• 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