K243643
- 510(k) number
- K243643
- Device name
- restor3d Reverse Total Shoulder Arthroplasty System
- Applicant
- Restor3D NC · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-05-19
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243643.pdf
Official FDA record: K243643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.