510(k) K172583 ยท HSB Rod, Fixation, Intramedullary And Accessories
OrthoPediatrics PediNail Intramedullary Platform
| Applicant | Orthopediatrics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 10, 2018 |
| Received | Aug 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2019 | OrthoPediatrics Corp OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system
(bolt is used to attach the targeting arm to the int Terminated |
HSB | None listed |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (pr Terminated |
HSB | None listed |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation r Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.