FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Mpact Constrained Liner
K Number: K241461
·
Decision Jul 31, 2025
Classifications
1
FEI Numbers
156
Registration Numbers
156
Same Product Code
33
Applicant Total
165
Review Days
434
Basic Information
- Device Name
- Mpact Constrained Liner
- K Number
- K241461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3310
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- May 23, 2024
- Decision Date
- July 31, 2025
- Product Code
- KWZ
- 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 |
|---|---|---|---|
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | FDA class 2 | Orthopedic |
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