FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Archer PSI System
K Number: K243509
·
Decision May 12, 2025
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
1
Review Days
181
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Basic Information
- Device Name
- Archer PSI System
- K Number
- K243509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D-Side
- Date Received
- November 12, 2024
- Decision Date
- May 12, 2025
- Product Code
- QHE
- 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 |
|---|---|---|---|
| QHE | Shoulder Arthroplasty Implantation System | FDA class 2 | Orthopedic |
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