K243509
- 510(k) number
- K243509
- Device name
- Archer PSI System
- Applicant
- 3D-Side BE
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2025-05-12
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243509.pdf
Official FDA record: K243509
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.