FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHARNLEY CONGENITAL HIP FEMUR (85-3060)
K Number: K761002
·
Decision Nov 23, 1976
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
58
Applicant Total
152
Review Days
15
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Basic Information
- Device Name
- CHARNLEY CONGENITAL HIP FEMUR (85-3060)
- K Number
- K761002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- November 8, 1976
- Decision Date
- November 23, 1976
- Product Code
- JDG
- 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 |
|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | FDA class 2 | Orthopedic |
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