FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Ligaments And Tendons, Synthetic
PMA: P850054
·
Decision Dec 30, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Ligaments And Tendons, Synthetic
- Trade Name
- STRKYER KNEE AUGMENTATION GRAFT
- PMA Number
- P850054
- Device Class
- FDA Class 3
- Product Code
- LML
- Generic Name
- LIGAMENTS AND TENDONS, SYNTHETIC
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 30, 1988
- Date Received
- August 5, 1985
- Expedited Review
- N
- Docket Number
- 89M-0043
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 |
|---|---|---|---|
| LML | Ligaments And Tendons, Synthetic | FDA class 3 | Unknown |