FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Intervertebral Disc
PMA: P100003
·
Supplement: S005
·
Decision Dec 18, 2014
Classifications
1
FEI Numbers
73
Registration Numbers
73
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- SECURE -C CERVICAL ARTIFICIAL DISC
- PMA Number
- P100003
- Supplement Number
- S005
- 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
- December 18, 2014
- Date Received
- July 5, 2013
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ADDITIONAL DEVICE SIZES.
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 |