510(k) K041393 ยท HSB Rod, Fixation, Intramedullary And Accessories
FASSIER-DUVAL TELSCOPIC IM SYSTEM
| Applicant | Pega Medical, Inc., Montreal (Quebec), CA |
| Decision | Substantially Equivalent, Aug 17, 2004 |
| Received | May 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2024 | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System Open, Classified |
LXH | None listed |
| Apr 29, 2015 | Pega Medical Inc. Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures.
This instrument is included in the Fassier-Duval IM Teles Terminated |
HSB | None listed |
| Apr 18, 2014 | Pega Medical Inc. Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.
-Duval IM Telescopic System. Terminated |
HSB | None listed |
| Apr 10, 2014 | Pega Medical Inc. Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. Terminated |
HSB | None listed |
| Mar 2, 2011 | Pega Medical Inc. Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.