FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
METAL TRANSCEND ARTICULATION SYSTEM
K Number: K004043
·
Decision Jul 13, 2001
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
44
Applicant Total
267
Review Days
196
Basic Information
- Device Name
- METAL TRANSCEND ARTICULATION SYSTEM
- K Number
- K004043
- Device Class
- FDA class 3
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Date Received
- December 29, 2000
- Decision Date
- July 13, 2001
- 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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