FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K Number: K061681
·
Decision Oct 19, 2006
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
90
Applicant Total
93
Review Days
126
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Basic Information
- Device Name
- REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
- K Number
- K061681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Manufacturing Corp
- Date Received
- June 15, 2006
- Decision Date
- October 19, 2006
- Product Code
- HRY
- 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 |
|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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