FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
RECLAIM Monobloc Revision Femoral Stem
K Number: K251292
·
Decision May 23, 2025
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
48
Review Days
28
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Basic Information
- Device Name
- RECLAIM Monobloc Revision Femoral Stem
- K Number
- K251292
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- April 25, 2025
- Decision Date
- May 23, 2025
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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