BONE GRAFT KIT 7510800 INFUSE LARGE II
INFUSE® Bone Graft - 7510800
Device Description
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.
Environmental Conditions
- 30.00
- 15.00
Device Sizes
- Large II
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MPW
Device Name: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
Device Class: 3
Physical State: N/A
Definition: Pma approved: P000054
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: 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 IdentifiersDevice Id: 00681490843829
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
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