FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW JERSEY ACETABULAR COMPONENT &
K Number: K842202
·
Decision Jul 20, 1984
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
4
Review Days
46
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Basic Information
- Device Name
- NEW JERSEY ACETABULAR COMPONENT &
- K Number
- K842202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Endomedics, Inc.
- Date Received
- June 4, 1984
- Decision Date
- July 20, 1984
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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