Cortoss 2101-0010

GUDID 00808232000979

Bone Augmentation Material

Stryker Corporation

Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable

• Primary Device ID: 00808232000979
• NIH Device Record Key: 7db5e61a-694c-4f43-874e-786cf3449806
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortoss
• Version Model Number: 2101-0010
• Catalog Number: 2101-0010
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• 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: true
• 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: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com
• Phone: +1(610)640-1775
• Email: inst.stryker.cs@stryker.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232000979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080108

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-09-24

On-Brand Devices [Cortoss]

• 00808232001372: Delivery Gun Kit
• 00808232000979: Bone Augmentation Material
• 00808232000962: Bone Augmentation Material
• 00808232000917: Delivery Gun
• 30808232000949: Mix Tips, Luer