FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL KNEE PROSTHESIS-NONCONSTRAINED
K Number: K771511
·
Decision Nov 30, 1977
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
331
Review Days
114
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Basic Information
- Device Name
- TOTAL KNEE PROSTHESIS-NONCONSTRAINED
- K Number
- K771511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- August 8, 1977
- Decision Date
- November 30, 1977
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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