FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MyPAO SA guides
K Number: K242603
·
Decision Nov 19, 2025
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
165
Review Days
446
Basic Information
- Device Name
- MyPAO SA guides
- K Number
- K242603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- August 30, 2024
- Decision Date
- November 19, 2025
- Product Code
- PBF
- 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 |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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