Archer PSI System
FDA 510(k) clearance K243509 · decided 2025-05-12
Clearance details
- K-number
- K243509
- Device name
- Archer PSI System
- Applicant
- 3D-Side
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-05-12
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- QHE
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mont-Saint-Guibert, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.