FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Intervertebral Disc
PMA: P120024
·
Supplement: S001
·
Decision Oct 21, 2015
Classifications
1
FEI Numbers
73
Registration Numbers
73
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- ACTIVL ARTIFICIAL DISC
- PMA Number
- P120024
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MJO
- Generic Name
- Prosthesis, intervertebral disc
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 21, 2015
- Date Received
- July 24, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGES TO THE ACTIVL INSTRUMENT TRAYS.
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 |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | FDA class 3 | Unknown |