FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
K Number: K931752
·
Decision Oct 7, 1994
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
5
Review Days
547
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Basic Information
- Device Name
- CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
- K Number
- K931752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin Orthopedic Products
- Date Received
- April 8, 1993
- Decision Date
- October 7, 1994
- 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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Other Clearances by Corin Orthopedic Products
| K Number | Device Name | ||
|---|---|---|---|
| K931753 | CORIN THOMPSON PROSTHESIS, MODIFICATION | Oct 7, 1994 | Substantially Equivalent for Some Indications |
| K934166 | NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION | Sep 7, 1994 | Substantially Equivalent for Some Indications |
| K925866 | CENATOR TOTAL HIP SYSTEM | Sep 23, 1993 | Substantially Equivalent |
| K925897 | CORIN BIPOLAR PROSTHESIS | Aug 9, 1993 | Substantially Equivalent |