FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM
K Number: K791823
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
96
Applicant Total
280
Review Days
46
Basic Information
- Device Name
- 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM
- K Number
- K791823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- 3M COMPANY
- Date Received
- September 14, 1979
- Decision Date
- October 30, 1979
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
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