510(k) K083286 ยท HRS Plate, Fixation, Bone
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Nov 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 14 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | None listed |
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 18 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | None listed |
| Aug 9, 2013 | OrthoPediatrics Corp 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. Terminated |
HWC | None listed |
| Nov 22, 2012 | OrthoPediatrics Corp 4.5mm PLEO Osteotomy Guide.
OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Terminated |
HRS | None listed |
| Jul 20, 2012 | OrthoPediatrics Corp OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.
Used for pediatric patients as indicated for pelvic, small and long bone fractures. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.