510(k) K243643 ยท PHX Shoulder Prosthesis, Reverse Configuration
restor3d Reverse Total Shoulder Arthroplasty System
| Applicant | Restor3D, Durham NC, US |
| Decision | Substantially Equivalent, May 19, 2025 |
| Received | Nov 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2026 | restor3d Inc. Brand Name: Veritas Standard Reverse Total Shoulder
Product Name: Veritas Standard Glenoid Baseplate
Model/Catalog Number: 1500-1030; 1500-1035
Software Version: N/A - off-the-shelf hardware product
P Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.