FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K Number: K831441
·
Decision Sep 1, 1983
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
303
Review Days
119
Basic Information
- Device Name
- POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
- K Number
- K831441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- DEPUY, INC.
- Date Received
- May 5, 1983
- Decision Date
- September 1, 1983
- Product Code
- MBV
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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