FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-FIT FEMORAL STEM
K Number: K010243
·
Decision Feb 15, 2001
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
57
Review Days
21
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Basic Information
- Device Name
- TRI-FIT FEMORAL STEM
- K Number
- K010243
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- January 25, 2001
- Decision Date
- February 15, 2001
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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