510(k) K111086 ยท HRS Plate, Fixation, Bone
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 17, 2011 |
| Received | Apr 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2015 | OrthoPediatrics Corp 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System
Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.