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

Bioactive Bone Graft Substitute, Foam Pack; Beta
Vitoss BA2X - 2102-2102

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.

• Total Volume: 2.5 Cubic Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MQV

Device Name: Filler, Bone Void, Calcium Compound

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3045

Third Party Flag: N

Medical Specialty: OR

Device Id: 00808232000689

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A