FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Intervertebral Disc
PMA: P070001
·
Supplement: S019
·
Decision Jul 7, 2022
Classifications
1
FEI Numbers
73
Registration Numbers
73
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo
- PMA Number
- P070001
- Supplement Number
- S019
- 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
- July 7, 2022
- Date Received
- December 18, 2020
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a Line Extension to Centinel Spines prodisc® C: the prodisc® C SK, the prodisc® C Nova, and the prodisc® C Vivo.
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 |