510(k) K202858 ยท HSB Rod, Fixation, Intramedullary And Accessories
Flex-ThreadTM Distal Fibula Intramedullary Nail System
| Applicant | Conventus Orthopaedics, LLC, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 22, 2021 |
| Received | Sep 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2023 | Flower Orthopedics Corporation Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is prov Open, Classified |
HSB | None listed |
| Nov 2, 2021 | Flower Orthopedics Corporation Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail Syste Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.