Palo Alto ™ LCM 23.25 MM

GUDID 00852587007732

CVBR LCM 23.25 MM

CARDINAL SPINE LLC

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00852587007732
• NIH Device Record Key: 3473709a-aac5-42fc-9e8e-87623de4c9e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palo Alto ™
• Version Model Number: LCM 23.25 MM
• Catalog Number: LCM 23.25 MM
• Company DUNS: 009915751
• Company Name: CARDINAL SPINE 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(502)245-5767
• Email: cardinalspinellc@gmail.com
• Phone: +1(502)245-5767
• Email: cardinalspinellc@gmail.com
• Phone: +1(502)245-5767
• Email: cardinalspinellc@gmail.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter
• Length: 12 Millimeter
• Width: 14 Millimeter
• Angle: 9 degree
• Height: 23.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852587007732 [Primary]
GS1	10888857386266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152568

FDA Product Code

• PLR: Spinal vertebral body replacement device - Cervical

Sterilization

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

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

[00852587007732]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-20