510(k) K110959 ยท HRS Plate, Fixation, Bone
ORTHOPEDIATRICS BLADE PLATE SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 5, 2011 |
| Received | Apr 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | None listed |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | None listed |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.