FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
K Number: K061844
·
Decision Dec 6, 2006
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
302
Review Days
160
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Basic Information
- Device Name
- DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
- K Number
- K061844
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wrightmedicaltechnologyinc
- Date Received
- June 29, 2006
- Decision Date
- December 6, 2006
- 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 |
Similar 510(k) Clearances
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