Vitoss BA2X 2102-2110

GUDID 00808232000702

Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass

Stryker Corporation

Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite

• Primary Device ID: 00808232000702
• NIH Device Record Key: 179eeb20-9e46-4115-8045-8b8ed0523c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitoss BA2X
• Version Model Number: 2102-2110
• Catalog Number: 2102-2110
• 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: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com

Device Dimensions

• Device Size Text, specify: 0
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Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232000702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102545

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [Vitoss BA2X]

• 00808232000702: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000696: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000689: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000672: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a