FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XR-SERIES BI-METRIC FEMORAL COMPONENTS
K Number: K052089
·
Decision Feb 17, 2006
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
32
Review Days
199
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Basic Information
- Device Name
- XR-SERIES BI-METRIC FEMORAL COMPONENTS
- K Number
- K052089
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Manufacturing, Inc.
- Date Received
- August 2, 2005
- Decision Date
- February 17, 2006
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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| K061340 | 23 MM SINGLE-PEG PATELLA COMPONENT | Sep 25, 2006 | Substantially Equivalent |
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