FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SELF-ALIGNING ACETABULAR COMPONENT
K Number: K831792
·
Decision Sep 20, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
4
Review Days
475
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Basic Information
- Device Name
- SELF-ALIGNING ACETABULAR COMPONENT
- K Number
- K831792
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Endomedics, Inc.
- Date Received
- June 3, 1983
- Decision Date
- September 20, 1984
- Product Code
- JDL
- 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 |
|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | FDA class 3 | Orthopedic |
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