Vitoss BiModal

Basic Information

• Brand Name: Vitoss BiModal
• Primary DI: 00808232000634
• Version / Model: 2102-1902
• Catalog Number: 2102-1902
• Company Name: Stryker Corporation
• Labeler DUNS: 149183167
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: 2dea928b-925a-4280-9f6e-35a3f06537f6

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQV	FILLER, BONE VOID, CALCIUM COMPOUND	Orthopedic	888.3045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47967	Bone matrix implant, composite	A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00808232000634	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103173	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Total Volume: 2.5 Cubic Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Ambient
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Expose to Extreme Heat
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Freeze