FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
PMA: P000058
·
Supplement: S043
·
Decision Aug 3, 2012
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 TAPERED FUSION DEVICE
- PMA Number
- P000058
- Supplement Number
- S043
- 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
- Approved
- Decision Code
- APPR
- Decision Date
- August 3, 2012
- Date Received
- February 15, 2011
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE SUBSTITUTION OF A QUALITY CONTROL TEST.
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 |