FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
PMA: P000058
·
Supplement: S069
·
Decision Aug 29, 2018
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
- Trade Name
- INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion Device
- PMA Number
- P000058
- Supplement Number
- S069
- Device Class
- FDA Class 3
- Product Code
- NEK
- Generic Name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 29, 2018
- Date Received
- August 2, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Add a pump to aid in manufacture.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEK | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | FDA class 3 | Unknown |