510(k) K210869 ยท HSB Rod, Fixation, Intramedullary And Accessories
Phantom Hindfoot TTC/TC Nail System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jun 28, 2021 |
| Received | Mar 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, 10.0 X 200mm, Right Open, Classified |
HSB | None listed |
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L Open, Classified |
HSB | None listed |
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.