BONE GRAFT KIT 7510400 INFUSE MEDIUM

BONE GRAFT KIT 7510400 INFUSE MEDIUM
INFUSE® Bone Graft - 7510400

A collection of sterile devices used to induce new spinal bone tissue that consists of a metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the protein and resulting bone growth. The bone morphogenetic protein is placed on the carrier/scaffold which is inserted into the spinal fusion cage. The spinal fusion cage is implanted into the spine and new bone tissue is induced at the site of implantation. The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD). This is a single-use device.

• Medium

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NEK

Device Name: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: NPZ

Device Name: Bone Grafting Material, Dental, With Biologic Component

Device Class: 3

Physical State: N/A

Definition: Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.

Submission Type ID: 2

Review Panel: DE

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: 872.3930

Third Party Flag: N

Medical Specialty: DE

Device Id: 00681490843805

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