FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORIN UNIPOLAR MODULAR HEAD
K Number: K063791
·
Decision Apr 3, 2007
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
57
Review Days
102
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Basic Information
- Device Name
- CORIN UNIPOLAR MODULAR HEAD
- K Number
- K063791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- December 22, 2006
- Decision Date
- April 3, 2007
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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