FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
K Number: K062994
·
Decision Mar 9, 2007
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
113
Applicant Total
83
Review Days
158
Basic Information
- Device Name
- LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
- K Number
- K062994
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMET MANUFACTURING CORP.
- Date Received
- October 2, 2006
- Decision Date
- March 9, 2007
- Product Code
- KWA
- 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 |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
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