510(k) K110805 ยท OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Jun 21, 2011 |
| Received | Mar 23, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110805
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.