FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MUTARS® femoral stem cemented 160 mm and 200 mm
K Number: K240391
·
Decision Oct 24, 2024
Classifications
1
FEI Numbers
284
Registration Numbers
284
Same Product Code
522
Applicant Total
4
Review Days
259
Basic Information
- Device Name
- MUTARS® femoral stem cemented 160 mm and 200 mm
- K Number
- K240391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantcast, GmbH
- Date Received
- February 8, 2024
- Decision Date
- October 24, 2024
- 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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