EPIPHANY PSL 50-10

GUDID B528PSL50100

EPIPHANY PEEK IMPLANT

PANTHEON SPINAL, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B528PSL50100
• NIH Device Record Key: e2d2c6f1-dc12-4f44-84dc-de8de66f9e21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIPHANY
• Version Model Number: 1
• Catalog Number: PSL 50-10
• Company DUNS: 071012634
• Company Name: PANTHEON SPINAL, 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

Customer Support Contacts

• Phone: 5122154888
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5122154888
• Email: INFO@PANTHEON-SPINAL.COM

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B528PSL50100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113781

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B528PSL50100]

Moist Heat or Steam Sterilization

[B528PSL50100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-01-20

On-Brand Devices [EPIPHANY]

• B582PSE55120: EPIPHANY 5/1 PEEK
• B528PSL60140: EPIPHANY PEEK IMPLANT
• B528PSL60120: EPIPHANY PEEK IMPLANT
• B528PSL60100: EPIPHANY PEEK IMPLANT
• B528PSL60080: EPIPHANY PEEK IMPLANT
• B528PSL55140: EPIPHANY PEEK IMPLANT
• B528PSL55120: EPIPHANY PEEK IMPLANT
• B528PSL55100: EPIPHANY PEEK IMPLANT
• B528PSL55080: EPIPHANY PEEK IMPLANT
• B528PSL50140: EPIPHANY PEEK IMPLANT
• B528PSL50120: EPIPHANY PEEK IMPLANT
• B528PSL50100: EPIPHANY PEEK IMPLANT
• B528PSL50080: EPIPHANY PEEK IMPLANT
• B528PSL45140: EPIPHANY PEEK IMPLANT
• B528PSL45120: EPIPHANY PEEK IMPLANT
• B528PSL45100: EPIPHANY PEEK IMPLANT
• B528PSL45080: EPIPHANY PEEK IMPLANT
• B528PSL40140: EPIPHANY PEEK IMPLANT
• B528PSL40120: EPIPHANY PEEK IMPLANT
• B528PSL40100: EPIPHANY PEEK IMPLANT
• B528PSL40080: EPIPHANY PEEK IMPLANT
• B528PSE60140: EPIPHANY 5/1 PEEK
• B528PSE60120: EPIPHANY 5/1 PEEK
• B528PSE60100: EPIPHANY 5/1 PEEK
• B528PSE60080: EPIPHANY 5/1 PEEK
• B528PSE55140: EPIPHANY 5/1 PEEK
• B528PSE55100: EPIPHANY 5/1 PEEK
• B528PSE55080: EPIPHANY 5/1 PEEK
• B528PSE50140: EPIPHANY 5/1 PEEK
• B528PSE50120: EPIPHANY 5/1 PEEK
• B528PSE50100: EPIPHANY 5/1 PEEK
• B528PSE50080: EPIPHANY 5/1 PEEK
• B528PSE45140: EPIPHANY 5/1 PEEK
• B528PSE45120: EPIPHANY 5/1 PEEK
• B528PSE45100: EPIPHANY 5/1 PEEK
• B528PSE45080: EPIPHANY 5/1 PEEK
• B528PSE40140: EPIPHANY 5/1 PEEK
• B528PSE40120: EPIPHANY 5/1 PEEK
• B528PSE40100: Epiphany 5/1 PEEK
• B528PSE40080: Epiphany 5/1 PEEK
• B5285714460: T-Handle
• B5285714400: Access Case
• B52810330: Implant Case
• B52810320: Disc Prep Case
• B52810310: Access Case
• B528102814000: 14MM ANGLED TRIAL
• B528102812000: 12MM ANGLED TRIAL
• B528102810000: 10MM ANGLED TRIAL
• B528102808000: 8MM ANGLED TRIAL
• B528102806000: 6MM ANGLED TRIAL