FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
CORAIL Cemented Femoral Stem
K Number: K231526
·
Decision Dec 19, 2023
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
48
Review Days
207
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Basic Information
- Device Name
- CORAIL Cemented Femoral Stem
- K Number
- K231526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- May 26, 2023
- Decision Date
- December 19, 2023
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
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