510(k) K083726 ยท HSB Rod, Fixation, Intramedullary And Accessories
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 11, 2009 |
| Received | Dec 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | OrthoPediatrics Corp OrthoPediatrics PediNail Intramedullary Nailing System
4.5mm X 48mm Cortical Screw Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-022.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-023.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-024.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025.
The system is used for pediatric and small stature adult patients to stabilize fractures o Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-031.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-032.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-033.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-035.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-036.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-071.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-072.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-073.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-074.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-075.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-076.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-081.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-084.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-086.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | None listed |
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