Yellowstone XL121830-8

GUDID B528XL12183080

Lateral Implant 12mm H x 18mm W x 30mm L - 8 degree Lordotic

PANTHEON SPINAL, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B528XL12183080
• NIH Device Record Key: fe0815a8-7125-4ef8-a2cc-6c3542b2b1fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yellowstone
• Version Model Number: 1
• Catalog Number: XL121830-8
• 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: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com
• Phone: 5123083488
• Email: info@pantheon-spinal.com

Device Dimensions

• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter
• Angle: 8 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B528XL12183080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170572

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

[B528XL12183080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-02

On-Brand Devices [Yellowstone]

• B528100213010: 13mm End Plate Scraper
• B528RXL0918500: SPACER LATERAL 18X50MM PEEK
• B528RXL0918450: SPACER LATERAL 18X45MM PEEK
• B528XL1214650: Lateral Implant 12mm H x 14mm W x 65mm L - Parallel
• B528XL1214600: Lateral Implant 12mm H x 14mm W x 60mm L - Parallel
• B528XL1214550: Lateral Implant 12mm H x 14mm W x 55mm L - Parallel
• B528XL1214500: Lateral Implant 12mm H x 14mm W x 50mm L - Parallel
• B528XL1214450: Lateral Implant 12mm H x 14mm W x 45mm L - Parallel
• B528XL1214400: Lateral Implant 12mm H x 14mm W x 40mm L - Parallel
• B528XL1214350: Lateral Implant 12mm H x 14mm W x 35mm L - Parallel
• B528XL1214300: Lateral Implant 12mm H x 14mm W x 30mm L - Parallel
• B528XL1214250: Lateral Implant 12mm H x 14mm W x 25mm L - Parallel
• B528XL1214200: Lateral Implant 12mm H x 14mm W x 20mm L - Parallel
• B528XL1014700: Lateral Implant 10mm H x 14mm W x 70mm L - Parallel
• B528XL1014650: Lateral Implant 10mm H x 14mm W x 65mm L - Parallel
• B528XL1014600: Lateral Implant 10mm H x 14mm W x 60mm L - Parallel
• B528XL1014550: Lateral Implant 10mm H x 14mm W x 55mm L - Parallel
• B528XL1014500: Lateral Implant 10mm H x 14mm W x 50mm L - Parallel
• B528XL1014450: Lateral Implant 10mm H x 14mm W x 45mm L - Parallel
• B528XL1014400: Lateral Implant 10mm H x 14mm W x 40mm L - Parallel
• B528XL1014350: Lateral Implant 10mm H x 14mm W x 35mm L - Parallel
• B528XL1014300: Lateral Implant 10mm H x 14mm W x 30mm L - Parallel
• B528XL1014250: Lateral Implant 10mm H x 14mm W x 25mm L - Parallel
• B528XL1014200: Lateral Implant 10mm H x 14mm W x 20mm L - Parallel
• B528XL0814700: Lateral Implant 8mm H x 14mm W x 70mm L - Parallel
• B528XL0814650: Lateral Implant 8mm H x 14mm W x 65mm L - Parallel
• B528XL0814600: Lateral Implant 8mm H x 14mm W x 60mm L - Parallel
• B528XL0814550: Lateral Implant 8mm H x 14mm W x 55mm L - Parallel
• B528XL0814500: Lateral Implant 8mm H x 14mm W x 50mm L - Parallel
• B528XL0814450: Lateral Implant 8mm H x 14mm W x 45mm L - Parallel
• B528XL0814400: Lateral Implant 8mm H x 14mm W x 40mm L - Parallel
• B528XL0814350: Lateral Implant 8m H x 14mm W x 35mm L - Parallel
• B528XL0814300: Lateral Implant, 8mm H x 14mm W x 30mm L - Parallel
• B528XL0814250: Lateral Implant, 8mm H x 14mm W x 25mm L - Parallel
• B528XL0814200: Lateral Implant, 8mm H x 14mm W x 20mm L - Parallel
• B528XL0614700: Lateral Implant, 6mm H x 14mm W x 70mm L - Parallel
• B528XL0614650: Lateral Implant, 6mm H x 14mm W x 65mm L - Parallel
• B528XL0614600: Lateral Implant, 6mm H x 14mm W x 60mm L - Parallel
• B528XL0614550: Lateral Implant, 6mm H x 14mm W x 55mm L - Parallel
• B528XL0614500: Lateral Implant, 6mm H x 14mm W x 50mm L - Parallel
• B528XL0614450: Lateral Implant, 6mm H x 14mm W x 45mm L - Parallel
• B528XL0614400: Lateral Implant, 6mm H x 14mm W x 40mm L - Parallel
• B528XL0614350: Lateral Implant, 6mm H x 14mm W x 35mm L - Parallel
• B528XL0614300: Lateral Implant, 6mm H x 14mm W x 30mm L - Parallel
• B528XL0614250: Lateral Implant, 6mm H x 14mm W x 25mm L - Parallel
• B528XL0614200: Lateral Implant, 6mm H x 14mm W x 20mm L - Parallel
• B528XL1814500: Lateral Implant 18mm H x 14mm W x 50mm L - Parallel
• B528XL1814450: Lateral Implant 18mm H x 14mm W x 45mm L - Parallel
• B528XL1814400: Lateral Implant 18mm H x 14mm W x 40mm L - Parallel
• B528XL1814350: Lateral Implant 18mm H x 14mm W x 35mm L - Parallel