FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW JERSEY FEMORAL RESURFACING COMPONENT
K Number: K842233
·
Decision Jul 20, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
22
Applicant Total
4
Review Days
45
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Basic Information
- Device Name
- NEW JERSEY FEMORAL RESURFACING COMPONENT
- K Number
- K842233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Endomedics, Inc.
- Date Received
- June 5, 1984
- Decision Date
- July 20, 1984
- Product Code
- KXA
- 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 |
|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | FDA class 2 | Orthopedic |
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